Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues or anatomical structures

ABSTRACT

Devices, systems and methods for retracting, lifting, compressing, supporting or repositioning tissues, organs, anatomical structures, grafts or other structures within the body of human or animal subjects for the purpose of treating a diseases or disorders and/or for cosmetic or reconstructive purposes and/or for research and development purposes or other purposes.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.11/134,870, now U.S. Pat. No. 7,758,594, filed Dec. 22, 2005, now U.S.Pat. No. 7,645,286, the entire disclosure of which is expresslyincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methods,and more particularly to systems and methods for retracting, lifting,compressing, supporting or repositioning tissues, organs, anatomicalstructures, grafts or other structures within the body of human oranimal subjects for the purpose of treating a diseases or disordersand/or for cosmetic or reconstructive purposes and/or for research anddevelopment purposes or other purposes.

BACKGROUND OF THE INVENTION

There are a wide variety of situations in which it is desirable to lift,compress or otherwise reposition normal or aberrant tissues oranatomical structures (e.g., organs, ligaments, tendons, muscles,tumors, cysts, fat pads, etc.) within the body of a human or animalsubject. Such procedures are often carried out for the purpose oftreating or palliating the effects of diseases or disorders (e.g.,hyperplasic conditions, hypertrophic conditions, neoplasias, prolapses,herniations, stenoses, constrictions, compressions, transpositions,congenital malformations, etc.) and/or for cosmetic purposes (e.g., facelifts, breast lifts, brow lifts, etc.) and/or for research anddevelopment purposes (e.g., to create animal models that mimic variouspathological conditions). In many of these procedures, surgicalincisions are made in the body and laborious surgical dissection isperformed to access and expose the affected tissues or anatomicalstructures. Thereafter, in some cases, the affected tissues oranatomical structures are removed or excised. In other cases, variousnatural or man made materials are used to lift, sling, reposition orcompress the affected tissues.

Benign Prostatic Hyperplasia (BPH)

One example of a condition where it is desirable to lift, compress orotherwise remove a pathologically enlarged tissue is Benign ProstaticHyperplasia (BPH). BPH is one of the most common medical conditions thataffect men, especially elderly men. It has been reported that, in theUnited Sates, more than half of all men have histopathologic evidence ofBPH by age 60 and, by age 85, approximately 9 out of 10 men suffer fromthe condition. Moreover, the incidence and prevalence of BPH areexpected to increase as the average age of the population in developedcountries increases.

The prostate gland enlarges throughout a man's life. In some men, theprostatic capsule around the prostate gland may prevent the prostategland from enlarging further. This causes the inner region of theprostate gland to squeeze the urethra. This pressure on the urethraincreases resistance to urine flow through the region of the urethraenclosed by the prostate. Thus the urinary bladder has to exert morepressure to force urine through the increased resistance of the urethra.Chronic over-exertion causes the muscular walls of the urinary bladderto remodel and become stiffer. This combination of increased urethralresistance to urine flow and stiffness and hypertrophy of urinarybladder walls leads to a variety of lower urinary tract symptoms (LUTS)that may severely reduce the patient's quality of life. These symptomsinclude weak or intermittent urine flow while urinating, straining whenurinating, hesitation before urine flow starts, feeling that the bladderhas not emptied completely even after urination, dribbling at the end ofurination or leakage afterward, increased frequency of urinationparticularly at night, urgent need to urinate etc.

In addition to patients with BPH, LUTS may also be present in patientswith prostate cancer, prostate infections, and chronic use of certainmedications (e.g. ephedrine, pseudoephedrine, phenylpropanolamine,antihistamines such as diphenhydramine, chlorpheniramine etc.) thatcause urinary retention especially in men with prostate enlargement.

Although BPH is rarely life threatening, it can lead to numerousclinical conditions including urinary retention, renal insufficiency,recurrent urinary tract infection, incontinence, hematuria, and bladderstones.

In developed countries, a large percentage of the patient populationundergoes treatment for BPH symptoms. It has been estimated that by theage of 80 years, approximately 25% of the male population of the UnitedStates will have undergone some form of BPH treatment. At present, theavailable treatment options for BPH include watchful waiting,medications (phytotherapy and prescription medications), surgery andminimally invasive procedures.

For patients who choose the watchful waiting option, no immediatetreatment is provided to the patient, but the patient undergoes regularexams to monitor progression of the disease. This is usually done onpatients that have minimal symptoms that are not especially bothersome.

Medications for treating BPH symptoms include phytotherapy andprescription medications. In phytotherapy, plant products such as SawPalmetto, African Pygeum, Serenoa Repens (sago palm) and South Africanstar grass are administered to the patient. Prescription medications areprescribed as first line therapy in patients with symptoms that areinterfering with their daily activities. Two main classes ofprescription medications are alpha-1a-adrenergic receptors blockers and5-alpha-reductase inhibitors. Alpha-1a-adrenergic receptors blockersblock that activity of alpha-1a-adrenergic receptors that areresponsible for causing constriction of smooth muscle cells in theprostate. Thus, blocking the activity of alpha-1a-adrenergic receptorscauses prostatic smooth muscle relaxation. This in turn reduces urethralresistance thereby reducing the severity of the symptoms.5-alpha-reductase inhibitors block the conversion of testosterone todihydrotestosterone. Dihydrotestosterone causes growth of epithelialcells in the prostate gland. Thus 5-alpha-reductase inhibitors causeregression of epithelial cells in the prostate gland and hence reducethe volume of the prostate gland which in turn reduces the severity ofthe symptoms.

Surgical procedures for treating BPH symptoms include TransurethralResection of Prostate (TURP), Transurethral Electrovaporization ofProstate (TVP), Transurethral Incision of the Prostate (TUIP), LaserProstatectomy and Open Prostatectomy.

Transurethral Resection of Prostate (TURP) is the most commonlypracticed surgical procedure implemented for the treatment of BPH. Inthis procedure, prostatic urethral obstruction is reduced by removingmost of the prostatic urethra and a sizeable volume of the surroundingprostate gland. This is carried out under general or spinal anesthesia.In this procedure, a urologist visualizes the urethra by inserting aresectoscope, that houses an optical lens in communication with a videocamera, into the urethra such that the distal region of the resectoscopeis in the region of the urethra surrounded by the prostate gland. Thedistal region of the resectoscope consists of an electric cutting loopthat can cut prostatic tissue when an electric current is applied to thedevice. An electric return pad is placed on the patient to close thecutting circuit. The electric cutting loop is used to scrape away tissuefrom the inside of the prostate gland. The tissue that is scraped awayis flushed out of the urinary system using an irrigation fluid. Using acoagulation energy setting, the loop is also used to cauterizetransected vessels during the operation.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Electrovaporization of the Prostate (TVP). In thisprocedure, a part of prostatic tissue squeezing the urethra isdesiccated or vaporized. This is carried out under general or spinalanesthesia. In this procedure, a resectoscope is insertedtransurethrally such that the distal region of the resectoscope is inthe region of the urethra surrounded by the prostate gland. The distalregion of the resectoscope consists of a rollerball or a grooved rollerelectrode. A controlled amount of electric current is passed through theelectrode. The surrounding tissue is rapidly heated up and vaporized tocreate a vaporized space. Thus the region of urethra that is blocked bythe surrounding prostate gland is opened up.

Another example of a surgical procedure for treating BPH symptoms isTransurethral Incision of the Prostate (TUIP). In this procedure, theresistance to urine flow is reduced by making one or more incisions inthe prostrate gland in the region where the urethra meets the urinarybladder. This procedure is performed under general or spinal anesthesia.In this procedure, one or more incisions are made in the muscle of thebladder neck, which is the region where the urethra meets the urinarybladder. The incisions are in most cases are deep enough to cut thesurrounding prostate gland tissue including the prostatic capsule. Thisreleases any compression on the bladder neck and causes the bladder neckto spring apart. The incisions can be made using a resectoscope, laserbeam etc.

Another example of a surgical procedure for treating BPH symptoms isLaser Prostatectomy. Two common techniques used for Laser Prostatectomyare Visual Laser Ablation of the Prostate (VLAP) and the Holmium LaserResection/Enucleation of the Prostate (HoLEP). In VLAP, aneodymium:yttrium-aluminum-garnet (Nd:YAG) laser is used to ablatetissue by causing coagulation necrosis. The procedure is performed undervisual guidance. In HoLEP, a holmium: Yttrium-aluminum-garnet laser isused for direct contact ablation of tissue. Both these techniques areused to remove tissue obstructing the urethral passage to reduce theseverity of BPH symptoms.

Another example of a surgical procedure for treating BPH symptoms isPhotoselective Vaporization of the Prostate (PVP). In this procedure,laser energy is used to vaporize prostatic tissue to relieve obstructionto urine flow in the urethra. The type of laser used is thePotassium-Titanyl-Phosphate (KTP) laser. The wavelength of this laser ishighly absorbed by oxyhemoglobin. This laser vaporizes cellular waterand hence is used to remove tissue that is obstructing the urethra.

Another example of a surgical procedure for treating BPH symptoms isOpen Prostatectomy. In this procedure, the prostate gland is surgicallyremoved by an open surgery. This is done under general anesthesia. Theprostate gland is removed through an incision in the lower abdomen orthe perineum. The procedure is used mostly in patients that have a large(greater than approximately 100 grams) prostate gland.

Minimally invasive procedures for treating BPH symptoms includeTransurethral Microwave Thermotherapy (TUMT), Transurethral NeedleAblation (TUNA), Interstitial Laser Coagulation (ILC), and ProstaticStents.

In Transurethral Microwave Thermotherapy (TUMT), microwave energy isused to generate heat that destroys hyperplastic prostate tissue. Thisprocedure is performed under local anesthesia. In this procedure, amicrowave antenna is inserted in the urethra. A rectal thermosensingunit is inserted into the rectum to measure rectal temperature. Rectaltemperature measurements are used to prevent overheating of theanatomical region. The microwave antenna is then used to delivermicrowaves to lateral lobes of the prostate gland. The microwaves areabsorbed as they pass through prostate tissue. This generates heat whichin turn destroys the prostate tissue. The destruction of prostate tissuereduces the degree of squeezing of the urethra by the prostate glandthus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Transurethral Needle Ablation (TUNA). In this procedure,heat induced coagulation necrosis of prostate tissue regions causes theprostate gland to shrink. It is performed using local anesthetic andintravenous or oral sedation. In this procedure, a delivery catheter isinserted into the urethra. The delivery catheter comprises tworadiofrequency needles that emerge at an angle of 90 degrees from thedelivery catheter. The two radiofrequency needles are aligned at anangle of 40 degrees to each other so that they penetrate the laterallobes of the prostate. A radiofrequency current is delivered through theradiofrequency needles to heat the tissue of the lateral lobes to 70-100degree Celsius at a radiofrequency power of approximately 456 KHz forapproximately 4 minutes per lesion. This creates coagulation defects inthe lateral lobes. The coagulation defects cause shrinkage of prostatictissue which in turn reduces the degree of squeezing of the urethra bythe prostate gland thus reducing the severity of BPH symptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is Interstitial Laser Coagulation (ILC). In this procedure,laser induced necrosis of prostate tissue regions causes the prostategland to shrink. It is performed using regional anesthesia, spinal orepidural anesthesia or local anesthesia (periprostatic block). In thisprocedure, a cystoscope sheath is inserted into the urethra and theregion of the urethra surrounded by the prostate gland is inspected. Alaser fiber is inserted into the urethra. The laser fiber has a sharpdistal tip to facilitate the penetration of the laser scope intoprostatic tissue. The distal tip of the laser fiber has adistal-diffusing region that distributes laser energy 360° along theterminal 3 mm of the laser fiber. The distal tip is inserted into themiddle lobe of the prostate gland and laser energy is delivered throughthe distal tip for a desired time. This heats the middle lobe and causeslaser induced necrosis of the tissue around the distal tip. Thereafter,the distal tip is withdrawn from the middle lobe. The same procedure ofinserting the distal tip into a lobe and delivering laser energy isrepeated with the lateral lobes. This causes tissue necrosis in severalregions of the prostate gland which in turn causes the prostate gland toshrink. Shrinkage of the prostate gland reduces the degree of squeezingof the urethra by the prostate thus reducing the severity of BPHsymptoms.

Another example of a minimally invasive procedure for treating BPHsymptoms is implanting Prostatic Stents. In this procedure, the regionof urethra surrounded by the prostate is mechanically supported toreduce the constriction caused by an enlarged prostate. Prostatic stentsare flexible devices that are expanded after their insertion in theurethra. They mechanically support the urethra by pushing theobstructing prostatic tissue away from the urethra. This reduces theconstriction of the urethra and improves urine flow past the prostategland thereby reducing the severity of BPH symptoms.

Although existing treatments provide some relief to the patient fromsymptoms of BPH, they have disadvantages. Alpha-1a-adrenergic receptorsblockers have side effects such as dizziness, postural hypotension,lightheadedness, asthenia and nasal stuffiness. Retrograde ejaculationcan also occur. 5-alpha-reductase inhibitors have minimal side effects,but only a modest effect on BPH symptoms and the flow rate of urine. Inaddition, anti-androgens, such as 5-alpha-reductase, require months oftherapy before LUTS improvements are observed. Surgical treatments ofBPH carry a risk of complications including erectile dysfunction;retrograde ejaculation; urinary incontinence; complications related toanesthesia; damage to the penis or urethra, need for a repeat surgeryetc. Even TURP, which is the gold standard in treatment of BPH, carriesa high risk of complications. Adverse events associated with thisprocedure are reported to include retrograde ejaculation (65% ofpatients), post-operative irritation (15%), erectile dysfunction (10%),need for transfusion (8%), bladder neck constriction (7%), infection(6%), significant hematuria (6%), acute urinary retention (5%), need forsecondary procedure (5%), and incontinence (3%) Typical recovery fromTURP involves several days of inpatient hospital treatment with anindwelling urethral catheter, followed by several weeks in whichobstructive symptoms are relieved but there is pain or discomfort duringmicturition.

The reduction in the symptom score after minimally invasive proceduresis not as large as the reduction in symptom score after TURP. Up to 25%of patients who receive these minimally invasive procedures ultimatelyundergo a TURP within 2 years. The improvement in the symptom scoregenerally does not occur immediately after the procedure. For example,it takes an average of one month for a patient to notice improvement insymptoms after TUMT and 1.5 months to notice improvement after ILC. Infact, symptoms are typically worse for these therapies that heat or cooktissue, because of the swelling and necrosis that occurs in the initialweeks following the procedures. Prostatic stents often offer moreimmediate relief from obstruction but are now rarely used because ofhigh adverse effect rates. Stents have the risk of migration from theoriginal implant site (up to 12.5% of patients), encrustation (up to27.5%), incontinence (up to 3%), and recurrent pain and discomfort. Inpublished studies, these adverse effects necessitated 8% to 47% ofstents to be explanted. Overgrowth of tissue through the stent andcomplex stent geometries have made their removal quite difficult andinvasive.

Thus the most effective current methods of treating BPH carry a highrisk of adverse effects. These methods and devices either requiregeneral or spinal anesthesia or have potential adverse effects thatdictate that the procedures be performed in a surgical operating room,followed by a hospital stay for the patient. The methods of treating BPHthat carry a lower risk of adverse effects are also associated with alower reduction in the symptom score. While several of these procedurescan be conducted with local analgesia in an office setting, the patientdoes not experience immediate relief and in fact often experiences worsesymptoms for weeks after the procedure until the body begins to heal.Additionally all device approaches require a urethral catheter placed inthe bladder, in some cases for weeks. In some cases catheterization isindicated because the therapy actually causes obstruction during aperiod of time post operatively, and in other cases it is indicatedbecause of post-operative bleeding and potentially occlusive clotformation. While drug therapies are easy to administer, the results aresuboptimal, take significant time to take effect, and often entailundesired side effects.

Urinary Incontinence (UI)

Many women experience loss of bladder control following childbirth or inold age. This condition is broadly referred to as urinary incontinence(UI). The severity of UI varies and, in severe cases, the disorder canbe totally debilitating, keeping the patient largely homebound. It isusually associated with a cystocele, which results from sagging of theneck of the urinary bladder into or even outside the vagina

The treatments for UI include behavioral therapy, muscle strengtheningexercises (e.g., Kegel exercises), drug therapy, electrical stimulationof the pelvic nerves, use of intravaginal devices and surgery.

In severe cases of UI, surgery is generally the best treatment option.In general, the surgical procedures used to treat UI attempt to lift andsupport the bladder so that the bladder and urethra are returned totheir normal positions within the pelvic cavity. The two most commonways of performing these surgeries is through incisions formed in theabdominal wall or though the wall of the vagina.

A number of different surgical procedures have been used to treat UI.The names for these procedures include the Birch Procedure,Marshall-Marchetti Operation, MMK, Pubo-Vaginal Sling, Trans-VaginalTape Procedure, Urethral Suspension, Vesicourethral Suspension. Theseprocedures generally fall into two categories, namely a) retropubicsuspension procedures and b) sling procedures.

In retropubic suspension procedures, an incision is typically made inthe abdominal wall a few inches below the navel and a network of suturesare placed to support the bladder neck. The sutures are anchored to thepubic bone and to other structures within the pelvis, essentiallyforming a cradle which supports the urinary bladder.

In sling procedures, an incision is typically made in the wall of thevagina and a sling is crafted of either natural tissue or synthetic(man-made) material to support the bladder neck. Both ends of the slingmay be attached to the pubic bone or tied in front of the abdomen justabove the pubic bone. In some sling procedures a synthetic tape is usedto form the sling and the ends of the synthetic tape are not tied butrather pulled up above the pubic bone.

The surgeries used to treat UI are generally associated with significantdiscomfort as the incisions heal and may require a Foley or supra-pubicurinary catheter to remain in place for at least several days followingthe surgery. Thus, there exists a need in the art for the development ofminimally invasive (e.g., non-incisional) procedures for the treatmentof UI with less postoperative discomfort and less requirement forpost-surgical urinary catheterization.

Cosmetic or Reconstructive Tissue Lifting and Repositioning

Many cosmetic or reconstructive surgical procedures involve lifting,compressing or repositioning of natural tissue, natural tissue orartificial grafts or aberrant tissue. For example, surgical proceduressuch as face lifts, brow lifts, neck lifts, tummy tucks, etc. havebecome commonplace. In many cases, these procedures are performed bycreating incisions through the skin, dissecting to a plane beneathmuscles and fascia, freeing the muscles, fascia and overlying skin fromunderlying structures (e.g., bone or other muscles), lifting orrepositioning the freed muscles, fascia and overlying skin and thenattaching the repositioned tissues to underlying or nearby structures(e.g., bone, periostium, other muscles) to hold the repositioned tissuesin their new (e.g., lifted) position. In some cases excess skin may alsobe removed during the procedure.

There have been attempts to develop minimally invasive devices andmethods for cosmetic lifting and repositioning of tissues. For example,suture suspension lifts have been developed where one end of a standardor modified suture thread is attached to muscle and the other end isanchored to bone, periostium or another structure to lift and repositionthe tissues as desired. Some of these suture suspension techniques havebeen performed through cannulas or needles inserted though relativelysmall incisions of puncture wounds.

For example, barbed threads known as Aptos threads may be insertedthrough a hollow trocar and used to lift tissues of the face in aprocedure that is performed commercially under the name Featherlift™(KMI, Inc. 2550 West Rowland Anaheim, Calif. 92804).

Another barbed thread that is useable for minimally invasive cosmeticlifting procedures is marketed under the name Contour Threads™ (SurgicalSpecialties Corporation, 100 Dennis Drive Reading, Pa. 19606).

There remains a need for the development of new devices and methods thatmay be used for various procedures where it is desired to lift,compress, support or reposition tissues or organs within the body withless intraoperative trauma, less post-operative discomfort and/orshorter recovery times.

SUMMARY OF THE INVENTION

The present invention provides systems and methods for retracting,lifting, compressing, supporting or repositioning an organ or tissuewithin the body of a human or animal subject. In these systems andmethods a first anchoring member (e.g., a distal anchor) is positionedat a first location, a second anchoring member (e.g., a proximal anchor)is positioned at a second location and a connector (e.g., an elongateconnector, tensioning member, filament, strand, thread, suture thread,string, wire, semi-rigid member, flexible member, elastic member,non-elastic member, resilient member, plastically deformable member,etc.) extends between the first and second anchoring members with asufficient distance or tension to bring about the desired retracting,lifting, compressing, supporting or repositioning of the organ ortissue. In some applications of the invention, the invention may be usedto facilitate volitional or non-volitional flow of a body fluid througha body lumen, modify the size or shape of a body lumen or cavity, treatprostate enlargement, treat urinary incontinence, support or maintainpositioning of a tissue, organ or graft, perform a cosmetic lifting orrepositioning procedure, form anastomotic connections, and/or treatvarious other disorders where a natural or pathologic tissue or organ ispressing on or interfering with an adjacent anatomical structure. Also,the invention has a myriad of other potential surgical, therapeutic,cosmetic or reconstructive applications, such as where a tissue, organ,graft or other material requires retracting, lifting, repositioning,compression or support.

Further in accordance with the invention, in some embodiments, a first(e.g., distal) anchor having the connector attached thereto is implantedat a first location within the subject's body. A second anchor (e.g.,proximal) is then advanced over the connector to a second location whereit is affixed to the connector such that the connector is under tensionand thereby retracts, lifts, compresses, supports or repositions saidorgan or tissue. Any excess or residual portion of the connector maythen be cut and removed. This embodiment of the invention may be used,for example, to treat enlargement of the prostate gland. When used totreat enlargement of the prostate gland, a first introducer may beinserted into the subject's urethra and a penetrator (e.g., a needle)may be advanced from the first introducer, through the wall of theurethra and into or through the prostate (e.g., at an extracapsularlocation outside of the prostate's connective tissue capsule, at anintracapsular location within the prostate capsule or at a sub-capsularlocation within the paryenchyma of the prostate). The first anchor (withthe connector attached thereto) is then deployed from the penetratorsuch that it becomes implanted at the desired first location. Thepenetrator may be retracted into the first introducer and the firstintroducer may be removed from the subject's urethra, leaving theconnector trailing from the implanted first anchor, through thepenetration tract created by the penetrator and into (or all the way outof) the subject's urethra. A second introducer bearing the second anchormay then be advanced over the trailing portion of the connector to asecond location where it is affixed to the connector to compressprostate tissue between the first and second anchors or otherwisereposition the prostate tissue so as to decrease compression of theurethra, thereby allowing normal or improved micturition while avoidingsubstantial resection or cutting of the urethral wall or prostate gland.In some applications, multiple sets of tissue anchors may be placed atdifferent locations to reposition the lobes of the prostate. In othercases, more than two anchors may be attached to a single connector suchthat more than two anchoring locations are established on thatconnector.

Still further in accordance with the invention, there are providedintroducer-delivery devices useable to install the tissue retracting,lifting, compressing, supporting or repositioning systems of theforegoing character. In some embodiments, device for delivering thefirst (e.g., distal) anchor may comprise an elongate shaft that isinsertable into a lumen or cavity of the subject's body and a penetrator(e.g., a needle) that is advanceable from the elongate shaft such thatthe penetrator penetrates into or through tissue. After the penetratorhas been advanced, the first (e.g., distal) anchor is deployed from thepenetrator such that it becomes implanted at the desired first locationwithin the subject's body. A handpiece may be provided on the proximalend of the elongate shaft. Such handpiece may incorporate one or moreactuators (e.g., triggers or other controls) for a) advancing/retractingthe penetrator and b) deploying the first (e.g., distal) anchor from thepenetrator. In some embodiments, a delivery device for delivering thesecond (e.g., proximal) anchor may comprise an elongate shaft with amechanism that holds the second (e.g., proximal) anchor. After the freeend of the connector has been inserted into the passageway of the secondanchor, the elongate shaft bearing the second anchor is advanced intothe body lumen or cavity such that the second (e.g., proximal) anchortracks over the connector and becomes cinched up to the desired secondposition. Then the second anchor is affixed to the connector at suchsecond position and released from the elongate shaft. Any residual orprotruding connector may be cut and the elongate shaft may then beremoved from the body lumen or cavity, leaving the first (e.g., distal)anchor, connector and second (e.g., proximal) anchor in place. Ahandpiece may be provided on the proximal end of this elongate member.Such handpiece may incorporate one or more actuators (e.g., triggers orother controls) for a) affixing (e.g., locking) the second anchor intothe connector, b) releasing the second anchor from the elongate shaftand c) optionally cutting away any residual portion of the connector.

Still further aspects and elements of the invention will become apparentto those of skill in the art upon reading of the detailed descriptionand examples set forth herebelow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland.

FIG. 1B shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland treatedwith an embodiment of the device of the present invention.

FIG. 1C shows a side view of an embodiment of the retractor shown inFIG. 1B.

FIGS. 1D through 1J show the various steps of a method of treating aprostate gland by the retractor shown in FIG. 1C.

FIG. 2A shows a sectional view through the embodiment of a distal anchorshown in FIG. 1C.

FIG. 2B shows a first embodiment of a flat pattern that can be used todesign the distal anchor of FIG. 2A.

FIG. 2C shows a second embodiment of a flat pattern that can be used todesign the distal anchor of FIG. 2A.

FIG. 2D shows a longitudinal sectional view through an embodiment of adistal anchor that is attached to a connector by a crimped loop.

FIG. 2E shows a longitudinal sectional view through an embodiment of adistal anchor that is attached to a connector by multiple crimped loops.

FIG. 2F shows a perspective view through an embodiment of a distalanchor that is attached to a connector by a buckle.

FIG. 2G shows a side view of the embodiment of a distal anchor of FIG.2F that is attached to a connector under tension.

FIG. 2H shows a perspective view of an embodiment of a distal anchorthat is attached to a connector by a knot.

FIG. 2I shows a longitudinal sectional view through an embodiment of adistal anchor that is attached to a connector by an adhesive.

FIG. 2J shows an alternate or complementary attachment mechanism.

FIG. 3A shows a side view of a first embodiment of a distal anchordelivery device.

FIG. 3B shows the distal anchor delivery device of FIG. 3A with aportion of the distal region removed.

FIG. 3C shows an enlarged view of the distal region 3C of FIG. 3B.

FIGS. 3D through 3K show various steps of a method of deploying a distalanchor in the anatomy by the distal anchor delivery device of FIG. 3A.

FIG. 3L shows a side view of a second embodiment of a distal anchordelivery device.

FIGS. 3M through 3T show steps of an embodiment of a method fordeploying the anchor of FIG. 3L in an anatomical region.

FIG. 3U shows a first side view of the distal tip of an embodiment of aneedle that can be used to introduce one or more of the distal anchorsdisclosed herein.

FIG. 3V shows a second side view of the distal tip of the embodiment ofthe needle shown in FIG. 3U.

FIG. 3W shows a longitudinal section through the distal tip of a distalanchor delivery device comprising a bushing to guide the trajectory of aneedle through the distal anchor delivery device.

FIG. 3X shows a longitudinal section through the distal tip of a distalanchor delivery device comprising a distal crimp or dimple to guide thetrajectory of a needle through the distal anchor delivery device.

FIG. 3Y shows a perspective view of the distal tip of a distal anchordelivery device comprising a bent, curved or angled needle introducinglumen.

FIG. 3Z shows a perspective view of an embodiment of a first elongatepart that is used to construct the distal end of the embodiment of thedistal anchor delivery device of FIG. 3Y.

FIG. 3A′ shows a perspective view of an embodiment of a second elongatepart that is used to construct the distal end of the embodiment of thedistal anchor delivery device of FIG. 3Y.

FIGS. 4A and 4B show longitudinal sections through a first embodiment ofa proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector.

FIG. 4C shows a first embodiment of a flat pattern that can be used todesign the proximal anchor of FIG. 4A.

FIGS. 4D and 4E show longitudinal sections through a second embodimentof a proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector.

FIGS. 4F and 4G show longitudinal sections through a third embodiment ofa proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector.

FIG. 4H shows an embodiment of a flat pattern that can be used to designthe proximal anchor of FIGS. 4F and 4G.

FIGS. 4I and 4J show longitudinal sections through a fourth embodimentof a proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector.

FIGS. 4K and 4L show longitudinal sections through a proximal anchorshowing the steps of an embodiment of a method of anchoring a connectorto a proximal anchor by an elongate wedging device comprising multiplebranches or bristles.

FIGS. 4M and 4N show longitudinal sections through an embodiment of aproximal anchor showing the steps of an embodiment of a method ofanchoring a connector to a proximal anchor by a lock pin pulled by aflexible pull shaft.

FIGS. 4O and 4P show longitudinal sections through an embodiment of aproximal anchor showing the steps of an embodiment of a method ofanchoring a connector to the proximal anchor by a hollow wedgingelement.

FIGS. 4Q and 4R show an embodiment of a method of using a compressioncutter for cutting the excess length of a connector and a wedgingelement.

FIGS. 4S and 4T show longitudinal sections through a first embodiment ofa proximal anchor comprising a crimping zone showing the steps of anembodiment of a method of anchoring a connector to the proximal anchor.

FIGS. 4U and 4V show longitudinal sections through a second embodimentof a proximal anchor comprising a crimping zone showing the steps of anembodiment of a method of anchoring a connector to the proximal anchor.

FIGS. 4W and 4X show a third embodiment of a proximal anchor comprisingmultiple crimping zones showing the steps of an embodiment of a methodof anchoring a connector to the proximal anchor.

FIG. 4Y shows a side view of an embodiment of a proximal anchorcomprising a tapering outer surface.

FIGS. 4Z through 4AB show side views of the embodiment of the proximalanchor of FIG. 4Y showing the steps of an embodiment of a method ofanchoring a connector to the proximal anchor by an anchoring ring.

FIG. 4AC shows a cross sectional view of an embodiment of the cuttingring of FIGS. 4M and 4AB.

FIG. 4AD shows a side view of a first embodiment of a proximal anchormade of a thermal shape memory alloy.

FIG. 4AE shows a cross section of the proximal anchor of FIG. 4ADthrough the line 4AE-4AE when the shape memory material of the proximalanchor is in the martensite phase.

FIG. 4AE′ shows a cross section of the proximal anchor of FIG. 4ADthrough the line 4AE-4AE when the shape memory material of the proximalanchor is in the programmed shape.

FIG. 4AF shows a cross section of the proximal anchor of FIG. 4ADthrough the line 4AF-4AF when the shape memory material of the proximalanchor is in the martensite phase.

FIG. 4AF′ shows a cross section of the proximal anchor of FIG. 4ADthrough the line 4AF-4AF when the shape memory material of the proximalanchor is in the programmed shape.

FIG. 4AG shows a side view of a second embodiment of a proximal anchormade of a thermal shape memory alloy.

FIG. 4AH shows a cross section of the proximal anchor of FIG. 4AGthrough the line 4AH-4AH when the shape memory material of the proximalanchor is in the martensite phase.

FIG. 4AH′ shows a cross section of the proximal anchor of FIG. 4AGthrough the line 4AH-4AH when the shape memory material of the proximalanchor is in the programmed shape.

FIGS. 4AI and 4AJ show longitudinal sections of an embodiment of aproximal anchor showing the steps of an embodiment of a method ofanchoring a looped or folded region of the connector to the proximalanchor.

FIG. 4AK shows a side view of an embodiment of a proximal anchor made ofa suitable elastic or super elastic or shape memory material comprisingone or more inwardly opening flaps.

FIG. 4AL shows a longitudinal section through the embodiment of theproximal anchor of FIG. 4AK.

FIG. 5A shows a side view of a first embodiment of a proximal anchordelivery device comprising one or more finger activated triggers.

FIGS. 5B through 5D show longitudinal sections through the distal tip ofthe proximal anchor delivery device of FIG. 5A showing the steps of amethod of deploying a proximal anchor in the anatomy.

FIG. 5E shows a side view of a proximal anchor similar to the proximalanchor in FIGS. 5B-5D having a undeployed lock pin partially insertedinto the proximal anchor.

FIGS. 5F through 5H show longitudinal sections through the proximalanchor and the lock pin of FIG. 5E showing the steps of a method ofattaching the proximal anchor to a connector using the lock pin.

FIG. 5I shows a side view of an embodiment of a lock pin that can beused to lock a connector to a proximal anchor as shown in the method ofFIGS. 5B-5D.

FIG. 5J shows another side view of the lock pin of connector shown inFIG. 5I.

FIG. 5K shows an isometric view of an embodiment of an actuator that canbe used to drive a lock pin into a proximal anchor.

FIG. 5L shows a side view of the embodiment of the actuator shown inFIG. 5K.

FIG. 5M shows a longitudinal section through the actuator of FIG. 5L.

FIG. 5N shows a side view of a second embodiment of a proximal anchordelivery device.

FIGS. 5O through 5S show the steps of an embodiment of a method ofdeploying an anchor in an anatomical region using the proximal anchordelivery device of FIG. 5N.

FIG. 5T shows the distal end of an embodiment of a proximal anchordelivery device comprising an anchor tube with a bent, curved or angleddistal end.

FIG. 5U shows the step of deploying a proximal anchor in an anatomicalregion by the proximal anchor delivery device of FIG. 5T.

FIG. 5V shows a cystoscopic view of a region of canine urethra enclosedby the prostate gland that has been treated by a procedure similar tothe procedure shown in FIGS. 1D through 1J.

FIG. 6A shows a side view of an embodiment of a distal anchor deliverydevice.

FIG. 6B shows an enlarged view of the distal region of the distal anchordelivery device of FIG. 6A showing the step of deploying a distal anchorby the distal anchor delivery device.

FIG. 6C shows a side view of an embodiment of a proximal anchor deliverydevice.

FIG. 6D shows an enlarged view of the distal region of the proximalanchor delivery device of FIG. 6C.

FIG. 6E shows the distal region of an embodiment of a proximal anchordelivery device comprising a curved penetrating distal tip.

FIG. 6F shows an embodiment of a retractor comprising a proximal anchorburied within an anatomical tissue by the proximal anchor deliverydevice of FIG. 6E.

FIG. 6G shows the distal region of an embodiment of a proximal anchordelivery device comprising a straight penetrating distal tip.

FIG. 6H shows an embodiment of a retractor comprising a proximal anchorburied within an anatomical tissue by the proximal anchor deliverydevice of FIG. 6G.

FIG. 6I shows a section through the distal tip of a first embodiment ofa combined device that can deliver a distal anchor connected to aproximal anchor by a connector.

FIG. 6J shows a side view of a second embodiment of a combined devicethat can deliver a distal anchor and a proximal anchor connected to eachother by a connector.

FIG. 6K shows another view of the embodiment of the combined deviceshown in FIG. 6J that can deliver a distal anchor and a proximal anchorconnected to each other by a connector.

FIGS. 6L through 6Q show the steps of a method of compressing ananatomical tissue by a combined device that delivers a proximal anchorand a distal anchor in the anatomy.

FIGS. 6R through 6W show the distal region of an embodiment of acombined device showing the steps of a method of delivering a retractorcomprising a proximal anchor and a distal anchor, wherein the distalanchor is delivered through the proximal anchor.

FIGS. 7A through 7H show a longitudinal section of a tubular organshowing the steps of a method of reducing the cross sectional area ofthe lumen of the tubular organ.

FIG. 7I shows a schematic diagram of a tubular organ showing theconfiguration of the tubular organ before performing the method shown inFIGS. 7A through 7H.

FIG. 7J shows a schematic diagram of the tubular organ of FIG. 7Ishowing a possible configuration obtained after performing the methodshown in FIGS. 7A through 7H.

FIG. 7K shows an embodiment of a distal anchor delivery devicecomprising a helical needle.

FIGS. 7L through 7N show a cross section of a tubular organ showing thesteps of a method of reducing the cross sectional area of the lumen ofthe tubular organ by creating one or more folds or pleats in the wallsof the tubular organ along the circumference of the lumen.

FIG. 7O shows a cross section of a tubular organ showing a firstembodiment of a method of compressing a tissue adjacent to a tubularorgan to cause one or more regions of the tissue to displace the wallsof the tubular organ thereby reducing the cross sectional area of thelumen of the tubular organ.

FIG. 7P shows a cross section of a tubular organ showing a secondembodiment of a method of compressing a tissue adjacent to a tubularorgan to cause one or more regions of the tissue to displace the wallsof the tubular organ thereby reducing the cross sectional area of thelumen of the tubular organ.

FIGS. 7Q through 7V show longitudinal sections of a tubular organshowing the steps of a method of reducing the cross sectional area ofthe lumen of the tubular organ by creating one or more folds or bulgesin the walls of the tubular organ along the axis of the tubular organ.

FIGS. 7W through 7Y shows cross sections of a tubular organ showing thesteps of a first embodiment of a method of reducing the cross sectionalarea of the lumen of the tubular organ by implanting a device thatpinches the walls of the tubular organ to create a recess.

FIGS. 7Z through 7AD show cross sections of a tubular organ showing thesteps of a second embodiment of a method of reducing the cross sectionalarea of the lumen of the tubular organ by implanting a device thatpinches the walls of the tubular organ to create a recess.

FIG. 7AE shows a cross section of a tubular organ showing the steps of afirst embodiment of a method of reducing the cross sectional area of thelumen of the tubular organ by implanting devices that pinch the walls ofthe tubular organ to create two recesses.

FIG. 7AF shows a cross section of a tubular organ showing a step of asecond embodiment of a method of reducing the cross sectional area ofthe lumen of the tubular organ by implanting devices that pinch thewalls of the tubular organ to create two recesses.

FIG. 7AG shows a cross section of a tubular organ showing a method ofreducing the cross sectional area of the lumen of the tubular organ bycreating a recess in the walls of the tubular organ and reinforcing therecessed region.

FIG. 8A shows an anchoring system implanted in a stomach to reduce thevolume of the stomach to treat obesity.

FIG. 8B shows a cross sectional view of a stomach before implanting ananchoring system to reduce the volume of the stomach.

FIG. 8C shows a cross sectional view of the stomach of FIG. 8B afterimplanting an anchoring system to reduce the volume of the stomach.

FIG. 8D shows a section through wound edges closed by an anchoringsystem in a first configuration.

FIG. 8E shows a section through wound edges closed by an anchoringsystem in a second configuration.

FIG. 8F shows an anchoring device used to reconnect torn tissues of themusculoskeletal system.

FIG. 8G shows a sagittal section through the head of a patient sufferingfrom sleep apnea.

FIG. 8H shows a sagittal section through the head of a patient sufferingfrom sleep apnea who has been treated with two anchoring devices thatdisplace the obstructing portions of the soft palate SP and the tongueTo.

FIG. 8I shows an anchoring system that is implanted to lift loose skinin the face of a human.

FIG. 8J shows a view of a human face showing facial regions that may betreated by a method similar to the method shown in FIG. 8I to improvethe cosmetic appearance of the human.

FIG. 8K shows a sagittal section through the lower abdomen of a humanfemale showing an embodiment of a method of treating female urinaryincontinence by a sling attached to the anatomy by anchoring devices.

FIG. 8L shows a cross section of a normal urethra UT.

FIG. 8M shows a cross section of the urethra UT in a human femalesuffering from stress urinary incontinence.

FIG. 8N shows a cross section of the urethra UT in a human femalesuffering from stress urinary incontinence where the urethra UT has beensupported with a sling.

FIG. 8O shows a section through the lower abdomen of a human femalesuffering from stress urinary incontinence where the urethra UT has beensupported with a sling.

FIG. 8P shows a section through the lower abdomen showing an embodimentof a colposuspension procedure wherein one or more regions of thevaginal wall of a patient suffering from incontinence are suspended tothe Cooper's ligament by one or more anchoring devices.

FIG. 8Q shows an anchoring device used to attach a seal to a puncturesite on a blood vessel BV to seal the puncture site.

FIG. 8R shows a view of the pectoral region of a human female.

FIG. 8S shows the pectoral region of a human female wherein mastopexyhas been performed on one or more regions of the breasts using theanchoring devices disclosed herein.

DETAILED DESCRIPTION

The following detailed description and the accompanying drawings areintended to describe some, but not necessarily all, examples orembodiments encompassed by the present invention.

A number of the drawings in this patent application show anatomicalstructures of the male reproductive and/or urinary system. In general,these anatomical structures are labeled with the following referenceletters:

-   -   Urethra UT    -   Urinary Bladder UB    -   Prostate Gland PG    -   Target Tissue TT    -   Urethral Wall UW    -   Ligament Li    -   Bone Bo    -   Pubic Bone PB    -   Soft Palate SP    -   Tongue To    -   Rectum R    -   Vagina V    -   Blood Vessel BV

FIG. 1A shows a coronal section (i.e., a section cut approximately inthe plane of the coronal suture or parallel to it) through the lowerabdomen of a male human suffering from BPH showing a hypertrophiedprostate gland. As depicted in FIG. 1A, the urinary bladder UB is ahollow muscular organ that temporarily stores urine. It is situatedbehind the pubic bone PB. The lower region of the urinary bladder has anarrow muscular opening called the bladder neck which opens into a soft,flexible, tubular organ called the urethra UT. The muscles around thebladder neck are called the internal urethral sphincter. The internalurethral sphincter is normally contracted to prevent urine leakage. Theurinary bladder gradually fills with urine until full capacity isreached, at which point the sphincters relax. This causes the bladderneck to open, thereby releasing the urine stored in the urinary bladderinto the urethra. The urethra conducts urine from the urinary bladder tothe exterior of the body. The urethra begins at the bladder neck andterminates at the end of the penis. The prostate gland PG is locatedaround the urethra at the union of the urethra and the urinary bladder.In FIG. 1A, the prostate gland is hypertrophied (enlarged). This causesthe prostate gland to press on a region of the urethra. This in turncreates an undesired obstruction to the flow of urine through theurethra.

FIG. 1B shows a coronal section through the lower abdomen of a malehuman suffering from BPH showing a hypertrophied prostate gland treatedwith an embodiment of the device of the present invention. It has beendiscovered that the enlarged prostate gland is compressible and can beretracted so as to relieve the pressure from the urethra. In accordancewith one embodiment of the present invention, a retractor device can beplaced through the prostate gland in order to relieve the pressure onthe urethra. In FIG. 1B, a retractor 10 is implanted in the prostategland. Retractor 10 comprises a distal anchor 12 and a proximal anchor14. Distal anchor 12 and a proximal anchor 14 are connected by aconnector 16. The radial distance from the urethra to distal anchor 12is greater than the radial distance from the urethra to proximal anchor14. The distance or tension between the anchors is sufficient tocompress, displace or change the orientation of an anatomical regionbetween distal anchor 12 and proximal anchor 14. The connector 16 can beinelastic so as to maintain a constant force or distance between theproximal and distal anchors or be elastic so as to attempt to draw theproximal and distal anchors closer together. In the embodiment shown inFIG. 1B, distal anchor 12 is located on the outer surface of the capsuleof prostate gland CP and acts as a capsular anchor. Alternatively,distal anchor 12 may be embedded inside the tissue of prostate gland PGor in the surrounding structures around the prostate such as periosteumof the pelvic bones, within the bones themselves, pelvic fascia, coopersligament, muscles traversing the pelvis or bladder wall. Also, in theembodiment shown in FIG. 1B, proximal anchor 14 is located on the innerwall of urethra UT and acts as a urethral anchor. Alternatively,proximal anchor 14 may be embedded inside the tissue of prostate glandPG or surrounding structures as outlined above. Distal anchor 12 andproximal anchor 14 are implanted in the anatomy such that a desireddistance or tension is created in connector 16. This causes distalanchor 12 and proximal anchor 14 to retract or compress a region ofprostate gland PG to relieve the obstruction shown in FIG. 1A. In FIG.1B, two retractors 10 are implanted in prostate gland PG. Each retractor10 is implanted in a lateral lobe (side lobe) of prostate gland PG. Thevarious methods and devices disclosed herein may be used to treat asingle lobe or multiple lobes of the prostate gland or other anatomicalstructures. Similarly, two or more devices disclosed herein may be usedto treat a single anatomical structure. For example, a lateral lobe ofprostate gland PG may be treated using two retractors 10. One or moreretractors may be deployed at particular angles to the axis of theurethra to target one or more lateral lobes and/or middle lobe of theprostate gland. In one embodiment, retractor 10 is deployed between the1 o'clock and 3 o'clock position relative to the axis of the urethra totarget the left lateral lobe of the prostate gland. In anotherembodiment, retractor 10 is deployed between the 9 o'clock and 11o'clock position relative to the axis of the urethra to target the rightlateral lobe of the prostate gland. In another embodiment, retractor 10is deployed between the 4 o'clock and 8 o'clock position relative to theaxis of the urethra to target the middle lobe of the prostate gland.

FIG. 1C shows a side view of one embodiment of the retractor shown inFIG. 1B. FIG. 1C shows retractor 10 comprising distal anchor 12 andproximal anchor 14. Distal anchor 12 and proximal anchor 14 areconnected by connector 16. In the embodiment shown in FIG. 1C, distalanchor 12 comprises a tube 18 having a lumen. Tube 18 can be made ofsuitable elastic or non-elastic materials including, but not limited tometals, polymers, etc. Typical examples of such materials include, butare not limited to stainless steel 304, stainless steel 316,nickel-Titanium alloys, titanium, Pebax, Polyimide, braided Polyimide,Polyurethane, Nylon, PVC, Hytrel, HDPE, PEEK, PTFE, PFA, FEP, EPTFE,shape memory polymers, such as polyesterurethane, polyetherurethane,polyetherpolyesters, polyetherpolyamines or combinations of oligoe-caprolactore diol and oligo p-dioxanone diol polymers, etc. Connector16 is attached to tube 18. In one embodiment, connector 16 is a USP size0 polypropylene monofilament suture. In the embodiment shown in FIG. 1C,a distal region of connector 16 is located in the lumen of tube 18 suchthat the distal tip of connector 16 emerges out of one end of the lumenof tube 18. The distal tip of connector 16 is enlarged, such that thediameter of the enlarged distal tip of connector 16 is greater than theinner diameter of tube 18. In one embodiment, the diameter of connector16 is 0.014 inches and the diameter of the enlarged distal tip ofconnector 16 is 0.025 inches. In one embodiment, the enlarged distal tipof connector 16 is created by controlled melting of the distal tip ofconnector 16. This attaches connector 16 to tube 18. Tube 18 maycomprise one or more additional attachment mechanisms to attach a distalregion of connector 16 to tube 18. In one embodiment, the distal regionof connector 16 is attached to tube 18 by a suitable biocompatibleadhesive. In the embodiment shown in FIG. 1C, the distal region ofconnector 16 is attached to tube 18 by one or more inwardly openingflaps 20 that are cut in the material of tube 18. Flaps 20 gripconnector 16 and thus prevent the relative motion of connector 16 andtube 18. The angle between one of flaps 20 and connector 16 may rangefrom 1 degree to 90 degrees. Tube 18 further comprises a longitudinalslot 22. Longitudinal slot 22 extends from one end to roughly the midsection of tube 18. Connector 16 emerges out of this longitudinal slot22. Thus, when connector 16 is pulled in the proximal direction, distalanchor 12 assumes a T-shape that helps to anchor distal anchor 12 to ananatomical structure. Distal anchor 12 may comprise a sharp edge to helppenetrate distal anchor 12 through the anatomy. In a preferredembodiment, distal anchor 12 is constructed by laser cutting anelectropolished nickel-titanium alloy (e.g., nitinol) tube made of 50.8%nickel-49.2% titanium. In the preferred embodiment, the outer diameterof tube 18 is 0.026 inches, the inner diameter of tube 18 is 0.015inches, the length of tube 18 is 0.315 inches and the length oflongitudinal slot 22 is 0.170 inches.

In the embodiment shown in FIG. 1C, proximal anchor 14 comprises a tube24 comprising a lumen. Tube 24 can be made of suitable elastic ornon-elastic materials including, but not limited to metals, polymers,etc. Typical examples of such materials include, but are not limited tostainless steel 304, stainless steel 316, nickel-Titanium alloys,titanium, Pebax, Polyimide, braided Polyimide, Polyurethane, Nylon, PVC,Hytrel, HDPE, PEEK, PTFE, PFA, FEP, ePTFE, such as polyesterurethane,polyetherurethane, polyetherpolyesters, polyetherpolyamines orcombinations of oligo e-caprolactone diol and oligo p-dioxanone diolpolymers, etc. An outwardly opening flap 26 is cut through the materialof tube 24. Flap 26 is folded on the outer surface of tube 18 as shownin FIG. 1C. This creates an opening to the lumen of tube 24 that islined by the atraumatic edge of the folded flap 26. Connector 16 enterstube 24 through this opening to the lumen of tube 24. Proximal anchor 14further comprises an attachment mechanism to attach connector 16 to tube24. Connector 16 can be made of suitable elastic or non-elasticmaterials including, but not limited to metals, polymers, etc. Typicalexamples of such materials include, but are not limited to stainlesssteel 304, stainless steel 316, nickel-Titanium alloys, suturematerials, titanium, silicone, nylon, polyamide, polyglycolic acid,polypropylene, Pebax, PTFE, ePTFE, silk, gut, or any other braided ormono-filament material. In a preferred embodiment, tube 24 has a lengthof 0.236 inches and an outer diameter of 0.027 inches and an innerdiameter of 0.020 inches. The length of opening to the lumen of tube 24is approximately 0.055 inches. In the preferred embodiment, theattachment mechanism comprises a lock pin that frictionally attachesconnector 16 to tube 24. The lock pin and tube 24 are made of stainlesssteel 316L. In the preferred embodiment, tube 24 is laser cut and thenelectropolished. Lock pin is constructed using EDM (electrical dischargemachining) and then passivated.

FIGS. 1D through 1J show the various steps of a method of treating aprostate gland by the retractor shown in FIG. 1C. Similar methods may bealso used to deploy retractor or compression devices in other anatomicalstructures. In the step shown in FIG. 1D, a sheath 28 such as a standardresectoscope sheath is introduced into the urethra (trans-urethrally).Sheath 28 is advanced through urethra UT such that the distal end ofsheath 28 is positioned near a region of urethra UT that is obstructedby a hypertrophied prostate gland PG. Distal anchor delivery device 30is introduced through sheath 28. Distal anchor delivery device 30 can beplaced in the sheath 28 after the distal end of sheath 28 is positionednear the region of the urethra UT that is obstructed or the distalanchor delivery device 30 can be pre-loaded in the sheath 28 beforepositioning of the sheath 28. Distal anchor delivery device 30 isadvanced through sheath 28 such that the distal end of distal anchordelivery device 30 emerges out of the distal end of sheath 28. Distalanchor delivery device 30 is oriented such that a working channelopening of distal anchor delivery device 30 points towards a laterallobe of prostate gland PG.

In the step shown in FIG. 1E, a needle 32 is introduced through distalanchor delivery device 30. Needle 32 can be placed in distal anchordelivery device after the distal anchor delivery device 30 is advancedthrough sheath 28 or the needle 32 can be pre-loaded in the distalanchor delivery device 30. In one embodiment, needle 32 is a 20 gaugeneedle. Needle 32 is advanced through distal anchor delivery device 30such that it emerges through the working channel opening. Needle 32 isfurther advanced such that it penetrates through the tissue of prostategland PG and the distal end of needle 32 emerges out of the capsule ofprostate gland CP.

In the step shown in FIG. 1F, distal anchor 12 connected to connector 16is advanced through needle 32. Distal anchor 12 can be pre-loaded inneedle 32 or can be loaded in needle 32 after needle 32 has beenadvanced through distal anchor delivery device 30. Distal anchor 12 isadvanced through needle 32 such that it emerges out of the distal end ofneedle 32.

In the step shown in FIG. 1G, needle 32 is removed from distal anchordelivery device 30 by pulling needle 32 in the proximal direction.

In the step shown in FIG. 1H, distal anchor delivery device 30 isremoved from sheath 28 by pulling distal anchor delivery device 30 inthe proximal direction. Also, connector 16 is pulled to orient distalanchor 12 perpendicularly to connector 16.

In the step shown in FIG. 1I, connector 16 is passed through proximalanchor 14 located on a proximal anchor delivery device 34. Proximalanchor delivery device 34 is advanced through sheath 28 such that thedistal end of proximal anchor delivery device 34 emerges out of thedistal end of sheath 28. A desired tension is introduced in connector 16such that distal anchor 12 is pulled by connector 16 with a desiredforce. Alternatively, the proximal anchor can be visualized through anendoscope or under fluoroscopy and advanced along the connector untilthe desired retraction of the tissue is achieved.

In the step shown in FIG. 1J, connector 16 is attached to proximalanchor 14. Proximal anchor 14 is also released from proximal anchordelivery device 34, thus deploying proximal anchor 14 in the anatomy.Proximal anchor delivery device 34 and sheath 28 are removed form theanatomy. Retractor 10 comprising distal anchor 12, proximal anchor 14and connector 16 is used to retract, lift, support, reposition orcompress a region of prostate gland PG located between distal anchor 12and proximal anchor 14. This method may be used to retract, lift,support, reposition or compress multiple regions or lobes of theprostate gland PG. In the method shown in FIGS. 1D through 1J, distalanchor 12 is deployed on the outer surface of the capsule of prostategland CP. Thus, distal anchor 12 acts as a capsular anchor.Alternatively, distal anchor 12 may be deployed inside the tissue ofprostate gland PG or beyond the prostate as outlined previously.Similarly, in the method shown in FIGS. 1D through 1J, proximal anchor14 is deployed on the inner wall of urethra UT and acts as a urethralanchor. Alternatively, proximal anchor 14 may be deployed inside thetissue of prostate gland PG.

FIG. 2A shows a sectional view through the embodiment of a distal anchorshown in FIG. 1C. In the embodiment shown in FIG. 2A, distal anchor 12comprises tube 18 comprising a lumen. Tube 18 is attached to a connector16. In the embodiment shown in FIG. 2A, a distal region of connector 16is located in the lumen of tube 18 such that the distal tip of connector16 emerges out of one end of the lumen of tube 18. Distal anchor 12and/or connector 16 comprise one or more attachment mechanisms to attachdistal anchor 12 to connector 16. In the embodiment shown in FIG. 2A,the attachment mechanism comprises an enlarged distal tip of connector16. In one embodiment, the enlarged distal tip is created by controlledmelting of the distal tip of connector 16. The enlarged distal tipanchors connector 16 to tube 18. In another embodiment, the attachmentmechanism comprises a suitable biocompatible adhesive that attaches thedistal region of connector 16 to tube 18. Other examples of attachmentmechanisms include, but are not limited to one or more knots onconnector 16, one or more turnbuckles on connector 16, crimped regionsof distal anchor 12, additional crimping elements that crimp onto theouter surface of connector 16, or crimping elements that fit inside thetube, etc. Tube 18 further comprises longitudinal slot 22. Longitudinalslot extends from one end to roughly the mid section of tube 18.Connector 16 emerges out of this longitudinal slot 22. Thus, whenconnector 16 is pulled in the proximal direction, distal anchor 12assumes a T-shape that helps to anchor distal anchor 12 to an anatomicalstructure. Distal anchor 12 may comprise a sharp edge to help penetratedistal anchor 12 through the anatomy. In one embodiment, distal anchor12 comprises a nickel-titanium alloy (e.g., nitinol) tube and connector16 comprises a polypropylene suture.

In one embodiment of a method of manufacturing distal anchor 12, a tubeis laser cut with a radially aligned laser. The geometry of the lasercut pattern is specified using a flat pattern drawing which is mappedonto the outside circumference of the tube. FIG. 2B shows a firstembodiment of a flat pattern that can be used to manufacture a distalanchor 12 of FIG. 2A. In FIG. 2B, flat pattern 36 comprises arectangular region. The length of the rectangular region represents thelength of the tube. The width of the rectangular region OC representsthe outer circumference of the tube. In one embodiment, the length ofthe rectangular region is 0.315+/−0.005 inches and the width of therectangular region is 0.088+/−0.001 inches. Flat pattern 36 furthercomprises a U-shaped slot 38 cut at the proximal end of flat pattern 36as shown in FIG. 2B. The width of slot 38 is 0404+/−0.002 inches. Thelength of the straight region of slot 38 is 0.174+/−0.005 inches. Thedistal end of slot 38 comprises a semi-circular region as shown in FIG.2B. The proximal end of slot 38 comprises rounded edges with a radius of0.2+/−0.005 inches. The distal region of flat pattern 36 may compriseone or more semicircular notches 40 that create inwardly opening flaps20. In the embodiment shown in FIG. 2B, flat pattern 36 comprises threenotches 40. In this embodiment, the width of notches 40 is 0.010+/−0.001inches. The length of the straight region of notches 40 is 0.010+/−0.001inches. The distal end of notches 40 comprises a semi-circular region asshown in FIG. 2B. A suitable connector 16 is passed through the lumen ofthe nickel-titanium alloy (e.g., nitinol) tube. Connector 16 is attachedto the distal end of the nickel-titanium alloy (e.g., nitinol) tube.Inwardly opening flaps 20 are crimped onto the outer surface ofconnector 16. This crimping produces additional anchoring sites on thenickel-titanium alloy (e.g., nitinol) tube to anchor connector 16 to thenickel-titanium alloy (e.g., nitinol) tube. The nickel-titanium alloy(e.g., nitinol) tube then acts as distal anchor 12. A region ofconnector 16 emerges out of distal anchor through slot 38. The diameterof slot 38 may be designed to allow the edges of slot 38 to accuratelycontact the outer surface of connector 16.

FIG. 2C shows a second embodiment of a flat pattern that can be used todesign distal anchor 12 of FIG. 2A. In FIG. 2C, flat pattern 42comprises a rectangular region. In one embodiment, the length of therectangular region is 0.354+/−0.005 inches and the width of therectangular region OC is 0.88+/−0.001 inches. Flat pattern 42 furthercomprises a W-shaped slot 44 cut at the proximal end of flat pattern 42as shown in FIG. 2C. The distal end of slot 44 comprises twosemi-circular regions as shown in FIG. 2C. In the embodiment shown inFIG. 2C, the radius of the semicircular regions is approximately 0.0015inches. The length of slot 44 measured along the length of flat pattern42 from the proximal end of flat pattern 42 to the proximal edges of thesemicircular regions is 0.174+/−0.005 inches. Slot 44 encloses a centralfolding tab 46. In the embodiment shown in FIG. 2C, folding tab 46comprises a straight proximal region and a tapering distal region. Thelength of the straight proximal region of folding tab 46 is 0.11+/−0.010inches. The length of the tapering distal region of folding tab 46 is0.040+/−0.005 inches. The proximal end of slot 44 has rounded edges witha radius of 0.020+/−0.005 inches. The distal region of flat pattern 42may comprise one or more semicircular notches 40. In the embodimentshown in FIG. 2C, flat pattern 42 comprises three notches 40 that createinwardly opening flaps 20. In this embodiment, the width of notches 40is 0.010+/−0.001X inches. The length of the straight region of notches40 is 0.010+/−0.001 inches. The distal end of notches 40 comprises asemi-circular region as shown in FIG. 2C. A suitable connector 16 ispassed through the lumen of the nickel-titanium alloy (e.g., nitinol)tube. Connector 16 is attached to the distal end of the nickel-titaniumalloy (e.g., nitinol) tube. Inwardly opening flaps 20 are crimped ontothe outer surface of connector 16. This crimping produces additionalanchoring sites on the nickel-titanium alloy (e.g., nitinol) tube toanchor connector 16 to the nickel-titanium alloy (e.g., nitinol) tube.The nickel-titanium alloy (e.g., nitinol) tube then acts as distalanchor 12. A region of connector 16 emerges out of distal anchor throughslot 44. To prevent or reduce the scraping of connector 16 by the distaledge of slot 44, a blunt edge is created at the distal edge of slot 44.This blunt edge is created by folding or bending folding tab 46 alongthe length of distal anchor 12. Several alternate designs of the bluntedge may be created using a variety of lengths of folding tab 46 and/ora variety of methods of folding or bending.

In the example shown in FIG. 2A, distal anchor 12 is attached toconnector 16 by an attachment mechanism comprising an enlarged distaltip of connector 16. Several alternate or complementary attachmentmechanisms are illustrated in FIGS. 2D-2J.

FIG. 2D shows a longitudinal sectional view through an embodiment of adistal anchor that is attached to a connector by a crimped loop. In FIG.2D, the distal end of connector 16 is looped. This looped distal end ofconnector 16 is inserted into distal anchor 12. Distal anchor 12 iscrimped to attach the looped distal end of connector 16 to distal anchor12.

FIG. 2E shows a longitudinal sectional view through an embodiment of adistal anchor that is attached to a connector by multiple crimped loops.In FIG. 2E, the distal end of connector 16 is folded multiple times toobtain multiple loops. These multiple loops of connector 16 are insertedinto distal anchor 12. Distal anchor 12 is crimped to attach themultiple loops of connector 16 to distal anchor 12.

FIG. 2F shows a perspective view through an embodiment of a distalanchor that is attached to a connector by a buckle. In FIG. 2F, thedistal end of connector 16 is passed through distal anchor 12. Thedistal end of connector 16 is passed through a buckle 47 and is looped.The distal end of connector 16 is inserted back into distal anchor 12.The distal end of connector 16 may be attached to distal anchor 12 byone or more mechanisms disclosed herein. In the embodiment shown in FIG.2F, the distal end of connector 16 is attached to distal anchor 12 by asuitable biocompatible adhesive. Distal anchor 12 may be crimped toattach connector 16 to distal anchor 12.

FIG. 2G shows a side view of the embodiment of a distal anchor of FIG.2F that is attached to a connector under tension. Buckle 47 prevents thelooped distal end of connector 16 from unraveling within distal anchor12.

FIG. 2H shows a perspective view of an embodiment of a distal anchorthat is attached to a connector by a knot. In FIG. 2H, the distal end ofconnector 16 is passed through distal anchor 12. The distal end ofconnector 16 is knotted. This knot attaches the distal end of connector16 to distal anchor 12.

FIG. 2I shows a longitudinal sectional view through an embodiment of adistal anchor that is attached to a connector by an adhesive. In FIG.2I, the distal end of connector 16 is passed through distal anchor 12.This distal end of connector 16 is attached to distal anchor 12 by asuitable biocompatible adhesive. Examples of biocompatible adhesivesthat can be used to attach connector 16 to proximal anchor 12 include,but are not limited to epoxies, cyanoacrylates and thermoplastics. Theinner surface of distal anchor 12 may be roughened or may be providedwith one or more projections or depressions to increase the strength ofthe attachment between connector 16 to proximal anchor 12.

The various distal anchors disclosed herein may be delivered by one ormore distal anchor delivery devices. Such distal anchor delivery devicesmay be introduced in the body of a human or animal through a variety ofaccess routes. For example, the prostate gland of a patient with BPH maybe treated by a distal anchor delivery device introducedtrans-urethrally.

FIG. 3A shows a side view of a first embodiment of a distal anchordelivery device 30. Distal anchor delivery device 30 comprises anelongate endoscope introducing tube 48. The endoscope introducing tube48 may range in length from 8 inches to 13 inches. In one embodiment,endoscope introducing tube 48 is made of stainless steel. The proximalend of endoscope introducing tube 48 may comprise an endoscope hub 50 tolock an endoscope to endoscope introducing tube 48. In the text theendoscope is used to mean any telescope, camera or optical system thatprovides visualization. In one embodiment, the endoscope is a 4 mmendoscope. A region of endoscope introducing tube 48 is attached to adistal handle assembly 52. In one embodiment, distal handle assembly 52is made of anodized aluminum, stainless steel and nickel-plated brasscomponents. The components may be fastened to each other by soldering,braising, welding or stainless steel fasteners. In the embodiment shownin FIG. 3A, distal handle assembly 52 comprises a distal attachment 54that encloses endoscope introducing tube 48. Distal attachment 54 isfurther attached to a distal handle 56. A region of endoscopeintroducing tube 48 proximal to distal handle assembly 52 passes througha proximal handle assembly 58. In one embodiment, proximal handleassembly 58 is made of machined acetal resin engineering plastic (e.g.,Delrin®, E.I. du Pont de Nemours and Company, Wilmington, Del.),polytetrafluoroethylene (PTFE), and nickel-plated brass components. Thecomponents may be fastened to each other by stainless steel fasteners.Proximal handle assembly 58 can slide over the outer surface ofendoscope introducing tube 48. In the embodiment shown in FIG. 3A,distal anchor delivery device 30 further comprises one or more guiderails 60. The distal ends of guide rails 60 are attached to a proximalsurface of distal attachment 54. Guide rails 60 pass through proximalhandle assembly 58 such that proximal handle assembly 58 can slide overthe outer surface of guide rails 60. Guide rails 60 help to stabilizethe orientation of proximal handle assembly 58 relative to distal handleassembly 52 during the relative motion of proximal handle assembly 58relative to distal handle assembly 52. Distal anchor delivery device 30further comprises an elongate needle introducing tube 62. Needleintroducing tube 62 is attached to endoscope introducing tube 48 asshown in FIG. 3A. In one embodiment, needle introducing tube 62 is madeof stainless steel. Needle introducing tube 62 passes through distalhandle assembly 52 and is attached to a region of distal handle assembly52. The distal tip of needle introducing tube 62 may comprise a curvedregion. The curved distal tip of needle introducing tube 62 is used todirect the exit trajectory of an elongate needle 32 that slides throughneedle introducing tube 62. In one embodiment, needle 32 is made ofnickel-titanium allow (e.g., nickel-titanium alloy (e.g., nitinol)) andcomprises a ground beveled tip. The proximal end of needle 32 isattached to proximal handle assembly 58. Thus a user can move needle 32through needle introducing tube 62 by moving proximal handle assembly 58along endoscope introducing tube 48. Distal anchor delivery device 30may comprise a needle stop to control the maximum movement of proximalhandle assembly 58 along endoscope introducing tube 48. This in turncontrols the maximum depth of penetration of needle 32 into a tissue.Needle 32 comprises a lumen through which a distal anchor deployingsystem is introduced in the anatomy. The distal anchor deploying systemis used to deploy distal anchor 12 in the anatomy. The distal anchordeploying system comprises a pusher 64 that pushes distal anchor 12 outof needle 32 and into the anatomy. In one embodiment, pusher 64 is madeof nickel-titanium alloy (e.g., nitinol). In the embodiment shown inFIG. 3A, the proximal end of pusher 64 is attached to a trigger 66 thatis attached to a proximal handpiece 68 of the proximal handle assembly58. Trigger 66 is attached to proximal handpiece 68 by a pivot 70. Thus,a user can move pusher 64 relative to needle 32 by moving trigger 66.Proximal handle assembly 58 further comprises a safety system 72 thatprevents unwanted motion of trigger 66. In the embodiment shown in FIG.3A, safety system 72 comprises a lock pin that locks trigger 66 toproximal handpiece 68. In one embodiment, the components of the safetysystem are made of stainless steel.

In one embodiment, distal anchor delivery device 30 is sized to beintroduced through a 25F cystoscope sheath. The length of distal anchordelivery device 30 within the sheath ranges from 6 to 10 inches. In thisembodiment, endoscope introducing tube 48 and endoscope hub 50 aredesigned to fit a 4 mm telescope. In this embodiment, the outer diameterof endoscope introducing tube 48 ranges from 0.174 to 0.200 inches andthe inner diameter of endoscope introducing tube 48 ranges from 0.160 to0.180 inches. In this embodiment, the outer diameter of needleintroducing tube 62 ranges from 0.059 to 0.83 inches and the innerdiameter of needle introducing tube 62 ranges from 0.041 to 0.072inches. In this embodiment, the outer diameter of needle 32 ranges from0.034 to 0.043 inches and the inner diameter of needle 32 ranges from0.027 to 0.035 inches. In this embodiment, the outer diameter of pusher64 ranges from 0.020 to 0.026 inches and the inner diameter of pusher 64ranges from 0.014 to 0.019 inches. In this embodiment, the radius of thecurved distal tip of needle introducing tube 62 ranges from 0.25 to 0.50inches. In this embodiment, the maximum distance through which proximalhandle assembly 58 can slide over the outer surface of endoscopeintroducing tube 48 ranges from 1 to 2 inches. In this embodiment, themaximum distance through which pusher 64 travels relative to needle 32ranges from 0.2 to 0.8 inches. In a preferred embodiment, distal anchordelivery device 30 is sized to be introduced through a 25F cystoscopesheath. The length of distal anchor delivery device 30 within the sheathis 9.5 inches. In this preferred embodiment, endoscope introducing tube48 and endoscope hub 50 are designed to fit a 4 mm telescope. In thispreferred embodiment, the outer diameter of endoscope introducing tube48 is 0.18 inches and the inner diameter of endoscope introducing tube48 is 0.16 inches. In this preferred embodiment, the outer diameter ofneedle introducing tube 62 is 0.083 inches and the inner diameter ofneedle introducing tube 62 is 0.072 inches. In this preferredembodiment, the outer diameter of needle 32 is 0.037 inches and theinner diameter of needle 32 is 0.030 inches. In this preferredembodiment, the outer diameter of pusher 64 is 0.025 inches and theinner diameter of pusher 64 is 0.020 inches. In this preferredembodiment, the radius of the curved distal tip of needle introducingtube 62 is 0.3 inches. In this preferred embodiment, the maximumdistance through which proximal handle assembly 58 can slide over theouter surface of endoscope introducing tube 48 is 1.7 inches. In thispreferred embodiment, the maximum distance through which pusher 64travels relative to needle 32 is 0.4 inches.

FIG. 3B shows the distal anchor delivery device of FIG. 3A with aportion of the distal region removed.

FIG. 3C shows an enlarged view of the distal region 3C of FIG. 3B. FIG.3C shows the distal end of distal anchor delivery device 30 comprisingelongate endoscope introducing tube 48 and needle introducing tube 62.

FIGS. 3D through 3K show various steps of a method of deploying distalanchor 12 in the anatomy by distal anchor delivery device 30 of FIG. 3A.For the description below regarding FIGS. 3D through 3K, the procedureis described as if applied to prostate gland although other anatomicalregions could be used. In FIG. 3D, an elongate sheath 28 is introducedin the urethra. In one embodiment, sheath 28 is a 25F cystoscoperesectoscope sheath. The position of sheath 28 is adjusted such that thedistal tip of sheath 28 is close to the region of the urethra enclosedby the prostate gland. In FIG. 3E, distal anchor delivery device 30 isintroduced through sheath 28 into the urethra. This step may performedunder endoscopic visualization by an endoscope 74 inserted in theendoscope introducing tube 48 of distal anchor delivery device 30.Distal anchor delivery device 30 may be rotated to orient the distal tipof needle introducing tube 62 in a desired orientation with respect toan anatomical organ such as the prostate gland. In FIG. 3F, proximalhandle assembly 58 is moved in the distal direction over endoscopeintroducing tube 48 relative to distal handle assembly 52. This in turncauses needle 32 to advance through needle introducing tube 62. Thedistal tip of needle 32 emerges out of the distal tip of needleintroducing tube 62. Needle 32 penetrates through one or more anatomicalregions. In one method embodiment, the distal tip of needle 32 emergesout of the capsule of the prostate gland and enters the surroundingpelvic space. In one method embodiment, the dimensions of the prostategland are measured. This information is then used to determine thedistance through which needle 32 is advanced through needle introducingtube 62. In FIG. 3G, safety system 72 is released. This step unlockstrigger 66 from proximal handpiece 68. In FIG. 3H, trigger 66 is lifted.This causes pusher 64 to advance in the distal direction through needle32. This in turn causes distal anchor 12 to emerge out through thedistal end of needle 32 and into the anatomy. In one method embodiment,distal anchor 12 emerges out of needle 32 and enters the surroundingpelvic space. In FIG. 3I, connector 16 is pulled in the proximaldirection. This causes distal anchor 12 to orient itself perpendicularlyto connector 16. In FIG. 3J, needle 32 is removed from the anatomy bypulling proximal handle assembly 58 in the proximal direction overendoscope introducing tube 48. In FIG. 3K, distal anchor delivery device30 is removed from the anatomy.

FIG. 3L shows a side view of a second embodiment of a distal anchordelivery device 30. Distal anchor delivery device 30 comprises anendoscope introducing tube 48. The proximal end of endoscope introducingtube 48 may comprise an endoscope hub 50 to lock an endoscope 74 toendoscope introducing tube 48. Endoscope introducing tube 48 encloses alumen through which endoscope 74 may be introduced into the anatomy.Distal anchor delivery device 30 comprises a needle introducing tube 62.Endoscope 74 is introduced through endoscope introducing tube 48 suchthat the distal end of needle introducing tube 62 is located near thedistal end of endoscope 74. Needle introducing tube 62 is used tointroduce a needle 32 into the anatomy. The distal end of needleintroducing tube 62 may comprise a curved, bent or tapered region tointroduce needle 32 into the anatomy at an angle to the axis ofendoscope 74. Needle introducing tube 62 is attached to endoscopeintroducing tube 48 by a coupling element 76. Distal anchor deliverydevice 30 may be introduced into the anatomy through a suitable sheath.Such as sheath may comprise a flushing or aspiration port. The flushingor aspiration port may be in fluid communication with the lumen of thesheath to allow a user to introduce fluids into or remove fluids from ananatomical region.

FIGS. 3M through 3T show perspective views of distal anchor deliverydevice 30 of FIG. 3L showing the steps of an embodiment of a method ofdeploying an anchor in an anatomical region. Distal anchor deliverydevice 30 comprises endoscope introducing tube 48 that encloses a lumen.An endoscope 74 is located in the lumen of endoscope introducing tube48. In the step shown in FIG. 3M, distal anchor delivery device 30 isintroduced in an anatomical region such as the urethra through anelongate sheath 28. Distal anchor delivery device 30 may be rotated toorient the distal tip of needle introducing tube 62 in a desiredorientation. A needle 32 is introduced through needle introducing tube62. In the step shown in FIG. 3N, needle 32 is advanced through needleintroducing tube 62 such that the distal end of needle 32 emerges out ofthe distal end of needle introducing tube 62 and enters an anatomicalregion. In one method embodiment, needle 32 is advanced such that thedistal end of needle 32 penetrates through the prostate gland and entersthe surrounding pelvic space. In this embodiment, the dimensions of theprostate gland may be measured. This information may then be used todetermine the distance through which distal end of needle 32 penetratesthrough the prostate gland. In the step shown in FIG. 3O, distal anchor12 attached to connector 16 is introduced into needle 32. Distal anchor12 is pushed in the distal direction through needle 32 by pusher 64. Inthe step shown in FIG. 3P, distal anchor 12 is further pushed in thedistal direction through needle 32 by pusher 64 such that distal anchor12 emerges out of the distal end of needle 32. In the step shown in FIG.3Q, connector 16 is pulled in the proximal direction. This causes distalanchor 12 to orient itself perpendicularly to connector 16. In the stepshown in FIG. 3R, needle 32 and pusher 64 are pulled along the proximaldirection. This step reintroduces the distal tip of needle 32 intoneedle introducing tube 62. In the step shown in FIG. 3S, pusher 64 andneedle 32 are pulled further along the proximal direction such thatpusher 64 and needle 32 are removed from distal anchor delivery device30. In the step shown in FIG. 3T, distal anchor delivery device 30 ispulled along the proximal direction to remove distal anchor deliverydevice 30 from the anatomy.

FIG. 3U shows a first side view of the distal tip of an embodiment of aneedle that can be used to introduce one or more of the distal anchorsdisclosed herein. FIG. 3U shows a needle 32 comprising a sharp distaltip. Needle 32 may be made of suitable biocompatible materialsincluding, but not limited to nickel-titanium alloy (e.g., nitinol),stainless steel, etc. Needle 32 may comprise one or more curved, bent orangled regions. The outer diameter of needle 32 may range from 0.034inches to 0.043 inches. Needle 32 encloses a lumen such that the innerdiameter of needle 32 ranges from 0.027 niches to 0.035 inches. In apreferred embodiment, the outer diameter of needle 32 is approximately0.0372 inches and the inner diameter is approximately 0.0295 inches. Thelength of needle 32 may range from 10 to 15 inches. In a preferredembodiment, length of needle 32 is 13+/−0.2 inches. In the embodimentshown in FIG. 3U, the distal tip of needle 32 has a first bevel 78 and asecond bevel 80. In a preferred embodiment, the angle between firstbevel 78 and the axis of needle 32 is 17 degrees. In this embodiment,the distance along the axis of needle 32 from the proximal end of firstbevel 78 to the distal end of needle 32 is approximately 0.12 inches.Second bevel 80 is curved as shown in FIG. 3U. In the embodiment shownin FIG. 3U, the distance along the axis of needle 32 from the proximalend of second bevel 80 to the distal end of needle 32 is approximately0.07 inches.

FIG. 3V shows a second side view of the distal tip of the embodiment ofthe needle shown in FIG. 3U. FIG. 3V shows a side view of needle 32showing first bevel 78 and second bevel 80.

In an alternate embodiment, the outer diameter of needle 32 is0.050+/−0.008 inches. Needle 32 encloses a lumen such that the innerdiameter of needle 32 is 0.038+/−0.008 inches. The length of needle 32is 12+/−4 inches. The angle between first bevel 78 and the axis ofneedle 32 may range from 20 to 24 degrees.

The distal tip of distal anchor delivery device 30 may comprise one ormore guiding mechanisms to accurately guide the trajectory of needle 32as needle 32 emerges from the distal tip of distal anchor deliverydevice 30. Such guiding mechanisms may also be used to prevent or reducethe scraping of the inner surface of distal anchor delivery device 30 bythe sharp distal end of needle 32. For example, FIG. 3W shows alongitudinal section through the distal tip of distal anchor deliverydevice 30 comprising a bushing 82 to guide the trajectory of needle 32through distal anchor delivery device 30. Bushing 82 may be made ofsuitable biocompatible materials including, but not limited tobiocompatible metals such as stainless steel, nickel-titanium alloy(e.g., nickel-titanium alloy (e.g., nitinol)), and/or polymers; etc. Inthe example shown in FIG. 3W, bushing 82 is made of a curved cylindricalmember. Bushing 82 lines the inner surface of distal anchor deliverydevice 30. In one embodiment, bushing 82 is attached to the innersurface of distal anchor delivery device 30 by a suitable adhesive. Thedistal end of bushing 82 is located proximal to the distal tip of distalanchor delivery device 30 as shown. This enables the distal sharp tip ofneedle 32 to emerge from the distal tip of distal anchor delivery device30 without substantially scraping the inner surface of distal anchordelivery device 30.

FIG. 3X shows a longitudinal section through the distal tip of distalanchor delivery device 30 comprising a distal crimp 84 or dimple toguide the trajectory of needle 32 through distal anchor delivery device30. Distal crimp 84 may be by crimping or dimpling the distal region ofdistal anchor delivery device 30 such that a region of distal crimp 84extends into the lumen of distal anchor delivery device 30. Distal crimp84 is located proximal to the distal tip of distal anchor deliverydevice 30 as shown. Distal crimp 84 acts as a ramp for needle 32. Thusneedle 32 emerges from the distal tip of distal anchor delivery device30 without substantially scraping the inner surface of distal anchordelivery device 30. Distal anchor delivery device 30 may comprise one ormore distal crimps 84 or dimples.

The distal tip of distal anchor delivery device 30 may comprise a bent,curved or angled tip. Such a bent, curved, or angled tip may be designedto introduce one or more devices such as needle 32 into the anatomy atan angle to the axis of distal anchor delivery device 30. In analternate embodiment, the distal tip of distal anchor delivery device 30comprises one or more bent, curved or angled lumens. For example, FIG.3Y shows a perspective view of the distal tip of distal anchor deliverydevice 30 comprising a bent, curved or angled needle introducing lumen86. Needle introducing lumen 86 may be used to introduce a needle 32 orother devices into the anatomy. In the embodiment shown in FIG. 3Y,needle introducing lumen 86 comprises a straight proximal region and abent, curved or angled distal region. The distal most region of needleintroducing lumen 86 may be oriented to the longitudinal axis of distalanchor delivery device 30 at an angle ranging from 30 degrees to 70degrees. In the embodiment shown in FIG. 3Y, distal anchor deliverydevice 30 further comprises a bent, curved or angled endoscopeintroducing lumen 88. Endoscope introducing lumen 88 may be used tointroduce an endoscope 74 or other devices into the anatomy. In theembodiment shown in FIG. 3Y, endoscope introducing lumen 88 comprises astraight proximal region and a bent, curved or angled distal region. Thedistal most region of endoscope introducing lumen 88 may be oriented tothe longitudinal axis of distal anchor delivery device 30 at an angle.Thus, both needle 32 and endoscope 74 may be introduced into the anatomyat desired angles through distal anchor delivery device 30.

In one embodiment, needle introducing lumen 86 may be made by drilling alumen through the distal region of distal anchor delivery device 30. Inanother embodiment, needle introducing lumen 86 is made of two groovedelongate parts that are attached to each other such that the two groovedelongate parts enclose needle introducing lumen 86. For example, theembodiment of the distal tip of distal anchor delivery device 30 shownin FIG. 3Y is made of two elongate parts: a first elongate part 90 and asecond elongate part 92. FIG. 3Y′ shows a perspective view of anembodiment of a first elongate part 90 that is used to construct thedistal end of an embodiment of distal anchor delivery device 30. Firstelongate part 90 comprises a first groove 94. First groove 94 has aD-shaped cross section. The diameter of the semi-circular region offirst groove 94 is approximately 0.045+/−0.005 inches. First elongatepart 90 further comprises a second groove 96. Second groove 96 also hasa D-shaped cross section. The diameter of the semi-circular region ofsecond groove 96 is approximately 0.172+/−0.010 inches. FIG. 3Z shows aperspective view of an embodiment of a second elongate part 92 that isused to construct the distal end of an embodiment of distal anchordelivery device 30. Second elongate part 92 comprises a third groove 98.Third groove 98 has a D-shaped cross section. First elongate part 90 andsecond elongate part 92 are attached to each other such that secondgroove 96 and third groove 98 form endoscope introducing lumen 88. Also,when first elongate part 90 and second elongate part 92 are attached toeach other, first groove 94 and an outer surface of second elongate part92 form a D-shaped needle introducing lumen 86.

FIGS. 4A and 4B show longitudinal sections through a first embodiment ofa proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector. In the embodiment shown inFIG. 4A, proximal anchor 14 comprises a hollow tube. The hollow tubecomprises a connector opening 100 located roughly midway between theends of the tube. In the embodiment shown in FIG. 4A, connector opening100 is made by cutting outwardly opening flap 26 in the material of thetube. Outwardly opening flap 26 is folded as shown in FIG. 4A to createa blunt edge to connector opening 100. Proximal anchor 14 furthercomprises a locking tab 102. Locking tab 102 is made by cutting a flapin the material of proximal anchor 14 and bending the flap into thelumen of proximal anchor 14 as shown. Connector 16 enters proximalanchor 14 through connector opening 100. Connector 16 emerges out ofproximal anchor 14 through the distal end of proximal anchor 14.Connector 16 can be attached to proximal anchor 14 by a lock pin 104.Lock pin 104 comprises an elongate body with a tapering distal tip. Lockpin 104 comprises a locking slot 106. Locking slot 106 is designed suchthat locking tab 102 fits into locking slot 106. This temporarily lockslock pin 104 to proximal anchor 14 as shown in FIG. 4A. In FIG. 4B, lockpin 104 is pushed in the distal direction by a user. This releaseslocking tab 102 from locking slot 106. This in turn releases lock pin104 from proximal anchor 14. Lock pin 104 then moves in the distaldirection. The tapering distal tip of lock pin 104 then wedges firmlybetween connector 16 and proximal anchor 14. This attaches connector 16to proximal anchor 14. Lock pin 104 and proximal anchor 14 may comprisefurther mechanisms to prevent relative motion between lock pin andproximal anchor 14 after connector 16 is attached to proximal anchor 14.

One or more edges of connector opening 100 may be smoothened. In onemethod embodiment, the edges are smoothened by applying a coating. Inanother method embodiment, the edges are smoothened by polishing. Inanother embodiment, the edges are smoothened by folding the materialaround connector opening 100.

In one embodiment of a method of manufacturing proximal anchor 104, atube is laser cut with a radially aligned laser. The geometry of thelaser cut pattern is specified using a flat pattern drawing which ismapped onto the outside circumference of the tube. FIG. 4C shows a firstembodiment of a flat pattern that can be used to manufacture proximalanchor 14 of FIG. 4A. The length of the rectangular region representsthe length of the tube. The width of the rectangular region OCrepresents the outer circumference of the tube. In FIG. 4C, third flatpattern 108 comprises a rectangular region. In one embodiment, thelength of the rectangular region is 0.236+/−0.005 inches and the widthof the rectangular region OC is 0.088+/−0.002 inches. Third flat pattern108 further comprises a U-shaped slot 110 cut at the proximal end ofthird flat pattern 108 as shown in FIG. 4C. The largest width of slot110 is 0.028+/−0.001 inches. The total length of slot 110 is0.050+/−0.002 inches. The proximal end of slot 110 encloses arectangular region as shown in FIG. 4C. The rectangular region is foldedto create outwardly opening flap 26. The distal end of slot 110comprises rounded edges with a radius of approximately 0.014 inches. Thedistal region of third flat pattern 108 comprises a second U-shaped slot112 as shown in FIG. 4C. In one embodiment of a method of manufacturingproximal anchor 14, a nickel-titanium alloy (e.g., nickel-titanium alloy(e.g., nitinol)) or stainless steel tube is cut according to third flatpattern 108. The rectangular region of slot 110 is bent outwards tocreate outwardly opening flap 26. The region enclosed by second U-shapedslot 112 is bent inwards to create locking tab 102.

FIGS. 4D and 4E show longitudinal sections through a second embodimentof a proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector. In the embodiment shown inFIG. 4D, proximal anchor 14 comprises a hollow tube. The hollow tubecomprises a connector opening 100 located roughly midway between theends of the tube. In the embodiment shown in FIG. 4D, connector opening100 is made by cutting outwardly opening flap 26 in the material of thetube. Outwardly opening flap 26 is folded as shown in FIG. 4D to createa blunt edge to connector opening 100. Connector 16 enters proximalanchor 14 through connector opening 100. Connector 16 emerges out ofproximal anchor 14 through a first shearing opening 114 of proximalanchor 14. Connector 16 can be attached to proximal anchor 14 by a lockpin 104. Lock pin 104 comprises an elongate body with a taperingproximal tip. Proximal anchor 14 further comprises a securing mechanismto prevent lock pin 104 from separating from proximal anchor 14. In theembodiment shown in FIG. 4D, the securing mechanism comprises a lockingcrimp 103. Locking crimp 103 is made by crimping a region of the wall ofproximal anchor 14. Locking crimp 103 prevents lock pin 104 fromaccidentally emerging from the distal end of proximal anchor 14. In theembodiment shown in FIG. 4D, proximal anchor further comprises a secondsecuring mechanism. The second securing mechanism comprises a lockingtab 102. Locking tab 102 fits into a locking slot 106 present on lockpin 104. This temporarily locks lock pin 104 to proximal anchor 14 asshown in FIG. 4D. Lock pin 104 further comprises a distal locking notch118 that is located distal to locking slot 106. Connector 16 is attachedto proximal anchor 14 by pulling an actuator 120 located on a proximalanchor delivery device 34. Actuator 120 comprises a distal bent regionas shown in FIG. 4D. The distal bent region of actuator 120 pulls thedistal end of lock pin 104 in the proximal direction. Actuator 120further comprises a second shearing opening 122, such that connector 16passes through second shearing opening 122. Proximal anchor is preventedfrom moving in the proximal direction by a holder 124 located on aproximal anchor delivery device 34.

In FIG. 4E, a user pulls actuator 120 in the proximal direction.Actuator 120 in turn pulls lock pin 104 in the proximal direction. Thisreleases locking tab 102 from locking slot 106. This in turn releaseslock pin 104 from proximal anchor 14. Lock pin 104 then moves in theproximal direction. The tapering proximal tip of lock pin 104 thenwedges firmly between connector 16 and proximal anchor 14. This attachesconnector 16 to proximal anchor 14. Also, locking tab 102 locks intodistal locking notch 118 thereby further securing lock pin 104 toproximal anchor 14. The movement of lock pin 104 in the proximaldirection also shears connector 16 between first shearing opening 114and second shearing opening 122. This cuts connector 16 therebyreleasing proximal anchor 14 from proximal anchor delivery device 34.

Connector 16 may enter or exit proximal anchor 14 through one or moreconnector openings. The walls of such openings may comprise one or morebent tabs. Such bent tabs may be bent inwards into the proximal anchorand may be used to wedge lock pin 104 to connector 16. For example,FIGS. 4F and 4G show longitudinal sections through a third embodiment ofa proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector. In the embodiment shown inFIG. 4F, proximal anchor 14 comprises a hollow tube. The hollow tubecomprises a connector opening 100 located roughly midway between theends of the tube. In the embodiment shown in FIG. 4F, connector opening100 is made by cutting an H-shaped slot in the material of the tube. TheH-shaped slot creates an outwardly opening flap 26. Outwardly openingflap 26 is folded as shown in FIG. 4F to create a blunt edge toconnector opening 100. The H-shaped slot also creates an inwardlyopening wedging tab 126 as shown in FIG. 4F. Proximal anchor 14 furthercomprises a locking tab 102. Locking tab 102 is made by cutting a flapin the material of proximal anchor 14 and bending the flap into thelumen of proximal anchor 14 as shown. Connector 16 enters proximalanchor 14 through connector opening 100. Connector 16 emerges out ofproximal anchor 14 through an end of proximal anchor 14. Connector 16can be attached to proximal anchor 14 by a lock pin 104. Lock pin 104comprises an elongate body with a tapering tip. Lock pin 104 comprises alocking slot 106. Locking slot 106 is designed such that locking tab 102fits into locking slot 106. This temporarily locks lock pin 104 toproximal anchor 14 as shown in FIG. 4F. In FIG. 4G, lock pin 104 ismoved by a user. This releases locking tab 102 from locking slot 106.This in turn releases lock pin 104 from proximal anchor 14. Lock pin 104then moves within proximal anchor 14 such that the tapering tip of lockpin 104 wedges firmly between connector 16 and proximal anchor 14.Further, wedging tab 126 gets wedged between lock pin 104 and connector16. This attaches connector 16 to proximal anchor 14. Lock pin 104 andproximal anchor 14 may comprise mechanisms to prevent relative motionbetween lock pin 104 and proximal anchor 14 after connector 16 isattached to proximal anchor 14.

In one embodiment of a method of manufacturing proximal anchors of FIGS.4F and 4G, a tube is laser cut with a radially aligned laser. Thegeometry of the laser cut pattern is specified using a flat patterndrawing which is mapped onto the outside circumference of the tube. FIG.4H shows an embodiment of a flat pattern that can be used to designproximal anchor 14 of FIGS. 4F and 4G. In FIG. 4H, fourth flat pattern128 comprises a rectangular region. In one embodiment, the length of therectangular region is 0.236+/−0.005 inches and the width of therectangular region OC is 0.088+/−0.002 inches. The proximal region offourth flat pattern 128 comprises a U-shaped slot 112 as shown in FIG.4H. Fourth flat pattern 128 further comprises an H-shaped slot 130 asshown in FIG. 4H. The largest width of slot 110 is 0.028+/−0.001 inches.The total length of slot 110 is 0.050+/−0.002 inches. In one embodimentof a method of manufacturing proximal anchor 14 of FIGS. 4F and 4G, anickel-titanium alloy (e.g., nickel-titanium alloy (e.g., nitinol)) orstainless steel tube is cut according to fourth flat pattern 128. Theproximal rectangular region created by H-shaped slot 130 is bentoutwards to create outwardly opening flap 26. The distal rectangularregion created by H-shaped slot 130 is bent inwards to create wedgingtab 126. The region created by U-shaped slot 112 is bent inwards tocreate locking tab 102.

FIGS. 4I and 4J show longitudinal sections through a fourth embodimentof a proximal anchor showing the steps of an embodiment of a method ofattaching the proximal anchor to a connector. Proximal anchor 14comprises a hollow tube. The tube comprises a proximal opening and adistal opening. Proximal anchor 14 further comprises multiple connectoropenings 198. Connector 16 is introduced through one connector opening100 and is weaved through the multiple connector openings 198 as shownin FIGS. 4I and 4J. The edges of connector openings 198 may be coated orpolished to facilitate smooth movement of proximal anchor 14 overconnector 16. Proximal anchor 14 further comprises lock pin 104 locatedin the lumen of proximal anchor 14. Proximal anchor 14 may comprise oneor more restricting elements to restrict the movement of lock pin 104within proximal anchor 14. In the embodiment shown in FIGS. 4I and 4J,proximal anchor 14 comprises two crimps 132 that act as restrictingelements. Crimps 132 prevent lock pin 104 from escaping from the lumenof proximal anchor 14. In the step shown in FIG. 4I, proximal anchor 14is advanced over connector 16 to position proximal anchor 14 in adesired location. In the step shown in FIG. 4J, lock pin 104 is advancedthrough proximal anchor 14. Lock pin 104 wedges between connector 16 andproximal anchor 14. This locks connector 16 to proximal anchor 14. Theexcess length of connector 16 may be cut or trimmed.

Several embodiments of lock pin 104 may be used to lock connector 16 toproximal anchor 14. Such lock pins 104 may comprise one or more taperedregions that wedge between connector 16 and a region of proximal anchor14. In addition, several alternate embodiments of wedging elements maybe used to attach connector 16 to a region of proximal anchor 14. Forexample, FIGS. 4K and 4L show longitudinal sections through a proximalanchor showing the steps of an embodiment of a method of anchoring aconnector to a proximal anchor by an elongate wedging device comprisingmultiple branches or bristles. In the embodiment shown in FIG. 4K,proximal anchor 14 comprises a connector opening 100 through which aconnector 16 passes. An elongate wedging element 134 also passes throughproximal anchor 14 such that one end of wedging element 134 can bepulled by a user. The embodiment of wedging element 134 shown in FIG. 4Kcomprises an elongate wedging shaft 136. One or more branches orbristles 138 are connected to wedging shaft 136. In one embodiment,wedging shaft 136 and bristles 138 are made of suitable polymericmaterials. Examples of such polymeric materials include, but are notlimited to polyester, polyimide, PEEK, polyurethane, etc. In oneembodiment, one or more bristles 138 are connected to each other to forma web. The movement of proximal anchor 14 is restricted by a stopper140. In the step shown in FIG. 4K, proximal anchor 14 is advanced overconnector 16 to position proximal anchor 14 in a desired location. Inthe step shown in FIG. 4L, a user pulls wedging element 134. This causesa region of wedging element 134 comprising one or more bristles 138 towedge between proximal anchor 14 and connector 16. This in turn locksconnector 16 to proximal anchor 14. The excess length of connector 16and/or wedging element 134 may be cut or trimmed.

The various wedging elements, lock pins, etc. disclosed herein may bedeployed using one or more flexible pull shafts. For example, FIGS. 4Mand 4N show longitudinal sections through an embodiment of a proximalanchor showing the steps of an embodiment of a method of anchoring aconnector to a proximal anchor by a lock pin pulled by a flexible pullshaft. In FIG. 4M, proximal anchor 14 comprises a hollow elongate bodycomprising a connector opening 100 through which a connector 16 passes.Proximal anchor 14 encloses an elongate lock pin 104 comprising atapering proximal end. A user can pull lock pin 104 in the proximaldirection by pulling an elongate flexible pull shaft 142. Flexible pullshaft 142 is detachably attached to lock pin 104. The movement ofproximal anchor 14 is restricted by a stopper 140. In the step shown inFIG. 4M, proximal anchor 14 is advanced over connector 16 to positionproximal anchor 14 in a desired location. In the step shown in FIG. 4N,flexible pull shaft 142 is pulled in the proximal direction by a user.This pulls lock pin 104 in the proximal direction. Lock pin 104 wedgesbetween connector 16 and proximal anchor 14. This locks connector 16 toproximal anchor 14. Flexible pull shaft 142 is detached from lock pin104. In one embodiment, the attachment between flexible pull shaft 142and lock pin 104 is designed to break at a pre-defined high force. Inthis embodiment, after the step of locking connector 16 to proximalanchor 14, flexible pull shaft 142 is pulled in the proximal directionat the pre-defined high force. This detaches flexible pull shaft 142from lock pin 104. In another embodiment, the attachment betweenflexible pull shaft 142 and lock pin 104 is electrolytically detachable.In this embodiment, after the step of locking connector 16 to proximalanchor 14, an electric current is passed through the attachment betweenflexible pull shaft 142 and lock pin 104. This electrolyticallydissolves the attachment between flexible pull shaft 142 and lock pin104. This in turn detaches flexible pull shaft 142 from lock pin 104.

FIGS. 4O and 4P show longitudinal sections through an embodiment of aproximal anchor showing the steps of an embodiment of a method ofanchoring a connector to the proximal anchor by a hollow wedgingelement. In FIG. 4O, proximal anchor 14 comprises a hollow elongate bodycomprising a connector opening 100 through which a connector 16 passes.Proximal anchor 14 encloses an elongate hollow wedging element 144comprising a tapering distal end. Hollow wedging element 144 is made ofsuitable high tensile strength materials such that hollow wedgingelement 144 can be pushed over connector 16. Examples of such materialsinclude, but are not limited to high stiffness polyimide, or PEEK, etc.The movement of proximal anchor 14 is restricted by a stopper 140. Inthe step shown in FIG. 4O, proximal anchor 14 is advanced over connector16 to position proximal anchor 14 in a desired location. Hollow wedgingelement 144 is advanced over connector 16 while pulling connector 16 inthe proximal direction. This causes hollow wedging element 144 to wedgebetween connector 16 and proximal anchor 14 as shown in FIG. 4P. This inturn attaches proximal anchor 14 to connector 16. In one embodiment, thelumen of hollow wedging element 144 is lined with one or more barbs orprojections. The one or more barbs or projections allow motion ofconnector 16 through the lumen of hollow wedging element 144 in onedirection and prevent or substantially resist motion of connector 16through the lumen of hollow wedging element 144 in the oppositedirection. In an alternate embodiment, wedging element 144 may benon-coaxial with connector 16. In another alternate embodiment, wedgingelement 144 may be pulled in a proximal direction in order to wedgewedging element 144 between connector 16 and proximal anchor 14.

The excess lengths of connector 16 and/or wedging elements may be cut ortrimmed using a variety of mechanisms. For example, FIGS. 4Q and 4R showan embodiment of a method of using a compression cutter for cutting theexcess length of connector 16 and a wedging element. In the step shownin FIG. 4Q, a connector 16 is attached to proximal anchor 14 by hollowwedging element 144. This may be done by the steps shown in FIGS. 4O-4P.A compression cutter 146 is advanced over hollow wedging element 144.Compression cutter 146 comprises two or more distal cutting edges. Theouter surface of the distal cutting edges comprises an enlarged regionas shown in FIG. 4Q. The enlarged region increases the radial profile ofcompression cutter 146 near the distal cutting edges. A compressingshaft 148 is advanced over compression cutter 146. In the step shown inFIG. 4R, compressing shaft 148 is advanced over the distal end ofcompression cutter 146. This exerts a radially inward force on thedistal cutting edges. This in turn compresses the distal cutting edgescausing them to cut the region of connector 16 and hollow wedgingelement 144 enclosed by the distal cutting edges. Thus excess lengths ofconnector 16 and hollow wedging element 144 are removed from proximalanchor 14.

FIGS. 4S and 4T show longitudinal sections through a first embodiment ofa proximal anchor comprising a crimping zone showing the steps of anembodiment of a method of anchoring a connector to the proximal anchor.In FIG. 4S, proximal anchor 14 comprises a hollow elongate bodycomprising a connector opening 100. A connector 16 enters proximalanchor 14 through connector opening 100. Connector 16 exits proximalanchor 14 through one end of proximal anchor 14. The proximal end ofproximal anchor 14 comprises a crimping zone 150. Crimping zone 150 canbe crimped by a suitable radial compressive force. Crimping zone 150 isenclosed by an elongate crimping device 152 as shown in FIG. 4S. Thedistal end of crimping device 152 may be used to maintain the positionof proximal anchor 14. The distal end of crimping device 152 iscompressed by a compressing shaft 148. In the step shown in FIG. 4S,proximal anchor 14 is advanced over connector 16 to position proximalanchor 14 in a desired location. In the step shown in FIG. 4T,compressing shaft 148 is advanced over crimping device 152 in the distaldirection till compression shaft 148 passes over the enlarged distal endof crimping device 152. This exerts a radially compressive force on thedistal end of crimping device 152. Crimping device 152 in turn exerts acompressive force on crimping zone 150. This force compresses crimpingzone 150 causing it to crimp over connector 16. This in turn causesproximal anchor 14 to attach to connector 16. The excess length ofconnector 16 may be cut or trimmed using a variety of cutting ortrimming mechanisms.

FIGS. 4U and 4V show longitudinal sections through a second embodimentof a proximal anchor comprising a crimping zone showing the steps of anembodiment of a method of anchoring a connector to the proximal anchor.Proximal anchor 14 comprises a hollow elongate body comprising aconnector opening 100. A connector 16 enters proximal anchor 14 throughconnector opening 100. Connector 16 exits proximal anchor 14 through oneend of proximal anchor 14. The proximal end of proximal anchor 14 can becrimped by a suitable radial compressive force. The proximal end ofproximal anchor 14 is enclosed by an elongate crimping shaft 154 asshown in FIG. 4U. Crimping shaft 154 encloses a lumen. The distal end ofthe lumen of crimping shaft 154 is tapered as shown in FIG. 4U, suchthat the diameter of the lumen gradually decreases till a certaindistance along the proximal direction. Connector 16 passes through thelumen of crimping shaft 154 as shown in FIG. 4U. The distal end ofcrimping shaft 154 and a region of proximal anchor delivery device 34may be used to maintain the position of proximal anchor 14. In the stepshown in FIG. 4U, proximal anchor 14 is advanced over connector 16 toposition proximal anchor 14 in a desired location. In the step shown inFIG. 4V, crimping shaft 154 is advanced in the distal direction. Theproximal end of proximal anchor 14 is forced into the lumen of crimpingshaft 154. The tapering lumen of crimping shaft 154 exerts a radiallycompressive force on the proximal end of proximal anchor 14. This forcecompresses the proximal end of proximal anchor 14 causing it to crimpover connector 16. This in turn causes proximal anchor 14 to attach toconnector 16. The excess length of connector 16 may be cut or trimmedusing a variety of cutting or trimming mechanisms.

Compression shaft 148 and crimping shaft 154 may be connected to atrigger mechanism to allow a user to controllably move compression shaft148 and crimping shaft 154.

FIGS. 4W and 4X show a third embodiment of a proximal anchor comprisingmultiple crimping zones showing the steps of an embodiment of a methodof anchoring a connector to the proximal anchor. In FIG. 4W, proximalanchor 14 comprises a hollow elongate body comprising a connectoropening. A connector 16 enters proximal anchor 14 through the connectoropening. Connector 16 exits proximal anchor 14 through one end ofproximal anchor 14. Proximal anchor 14 comprises multiple crimping zones150. Crimping zones 150 can be crimped by a suitable radial compressiveforce. In the embodiment of proximal anchor shown in FIG. 4W, proximalanchor 14 comprises three crimping zones 150. The crimping zones 150 arecreated in the material of proximal anchor 14 by creating U-shaped lasercuts. Each U-shaped cut encloses a flap that acts as a crimping zone150. In the embodiment shown in FIG. 4W, the U-shaped laser cuts arealigned circumferentially. In an alternate embodiment, the U-shapedlaser cuts are aligned along the axis of proximal anchor 14. The regionof proximal anchor 14 comprising crimping zones 150 is enclosed by anelongate crimping device 152 as shown in FIG. 4W. The lumen of crimpingdevice 152 may comprise one or more projections that coincide withcrimping zones 150. The distal end of crimping device 152 comprises atapering region as shown in FIG. 4W such that the outer diameter ofcrimping device 152 increases along the distal direction. The distal endof crimping device 152 is compressed by a compressing shaft 148. In thestep shown in FIG. 4W, proximal anchor 14 is advanced over connector 16to position proximal anchor 14 in a desired location. In the step shownin FIG. 4X, compressing shaft 148 is advanced over crimping device 152in the distal direction till compression shaft 148 passes over thetapering distal end of crimping device 152. This exerts a radiallycompressive force on the distal end of crimping device 152. Crimpingdevice 152 in turn exerts a compressive force on crimping zones 150.This force compresses crimping zones 150 causing them to crimp overconnector 16. This in turn causes proximal anchor 14 to attach toconnector 16. The excess length of connector 16 may be cut or trimmedusing a variety of cutting or trimming mechanisms.

FIG. 4Y shows a side view of an embodiment of a proximal anchorcomprising a tapering outer surface. In the embodiment shown in FIG. 4Y,proximal anchor 14 comprises an elongate tapering body with effectivediameter “d” at one end smaller than effective diameter “D” at the otherend. Proximal anchor 14 further comprises an external groove or slot 156on the outer surface of the elongate tapering body. Examples of suitablebiocompatible materials that may be used to construct proximal anchor 14include, but are not limited to metals e.g. nickel-titanium alloy (e.g.,nickel-titanium alloy (e.g., nitinol)), stainless steel, titanium,polymers (e.g. polyester, polyimide, PEEK, polyurethane, etc.

FIGS. 4Z through 4AB show side views of the embodiment of the proximalanchor of FIG. 4Y showing the steps of an embodiment of a method ofanchoring a connector to the proximal anchor by an anchoring ring. Inthe step shown in FIG. 4Z, proximal anchor 14 is positioned at a desiredlocation in the anatomy along a connector 16 such that a portion ofconnector 16 passes through slot 156. An anchoring ring 158 is advancedover proximal anchor 14. Examples of suitable biocompatible materialsthat may be used to construct anchoring ring 158 include, but are notlimited to metals e.g. nickel-titanium alloy (e.g., nitinol), stainlesssteel, titanium, etc.; polymers e.g. polyester, polyimide, PEEK,polyurethane, etc. Anchoring ring 158 is advanced over proximal anchor14 by a suitable pushing device. In one embodiment, the pushing deviceis a hollow, elongate pushing rod. As anchoring ring 158 is advancedover proximal anchor 14, the diameter of the region of proximal anchor14 enclosed by anchoring ring 158 increases. After anchoring ring 158 isadvanced to a certain distance along proximal anchor 14, anchoring ring158 firmly grips the outer surface of proximal anchor 14. This causes aregion of connector 16 to be compressed between a region of anchoringring 158 and a region of proximal anchor 14. This in turn causesproximal anchor 14 to attach to connector 16. The excess length ofconnector 16 may be cut or trimmed using a variety of cutting ortrimming mechanisms. In one embodiment of a method of cutting ortrimming connector 16, a cutting ring 160 is advanced over proximalanchor 14 as shown in FIG. 4AA. Examples of suitable biocompatiblematerials that may be used to construct cutting ring 160 include, butare not limited to metals e.g. nickel-titanium alloy (e.g., nitinol),stainless steel, titanium, etc.; polymers e.g. polyester, polyimide,PEEK, polyurethane, etc. Cutting ring 160 comprises a circular body thatis attached to a cutting blade 162. As cutting ring 160 is advanced overproximal anchor 14, the diameter of the region of proximal anchor 14enclosed by cutting ring 160 increases. After cutting ring 160 isadvanced to a certain distance along proximal anchor 14, cutting blade162 comes into contact with a region of connector 16. Cutting ring 160is advanced further to cut connector 16 by cutting blade 162 as shown inFIG. 4AB.

FIG. 4AC shows a cross sectional view of an embodiment of the cuttingring of FIGS. 4AA and 4AB. In the embodiment shown in FIG. 4AC, cuttingring 160 comprises a circular body that is attached to a cutting blade162 that projects radially inwards.

FIG. 4AD shows a side view of a first embodiment of a proximal anchormade of a thermal shape memory alloy. In FIG. 4AD, proximal anchor 14comprises a hollow elongate body made of a suitable shape memorymaterial. Examples of such shape memory materials include, but are notlimited to nickel-titanium alloys (nickel-titanium alloy (e.g.,nitinol)), copper-aluminum-nickel alloys, copper-zinc-aluminum alloys,iron-manganese-silicon alloys, etc. In the embodiment shown in FIG. 4AD,proximal anchor 14 is made of nickel-titanium alloy (e.g., nitinol).Proximal anchor 14 encloses a lumen. One end of proximal anchor 14 maybe plugged by a lumen plug 164. In the embodiment shown in FIG. 4AD,proximal anchor 14 also comprises a longitudinal slit. The longitudinalslit creates a fluid communication between the lumen of proximal anchor14 and the exterior of proximal anchor 14. Proximal anchor 14 comprisesa connector opening 100. A connector 16 enters proximal anchor 14through connector opening 100. Connector 16 exits proximal anchor 14through one end of proximal anchor 14. A user can control the diameterof the lumen of proximal anchor 14 by changing the temperature ofproximal anchor 14. In one embodiment of a method of anchoring proximalanchor 14 to connector 16, proximal anchor 14 is introduced in theanatomy in the martensite phase of the shape memory material of proximalanchor 14. The diameter of the lumen of proximal anchor 14 in themartensite state is sufficiently large to allow proximal anchor 14 to beadvanced over connector 16. The martensite phase may be achieved forexample, by cooling proximal anchor 14 and introducing the cooledproximal anchor 14 in the anatomy. After proximal anchor 14 warms up tothe body temperature, the shape memory material recovers a programmedshape and becomes super-elastic. In the programmed shape, the diameterof the lumen of proximal anchor 14 is sufficiently small to allowproximal anchor 14 to attach to connector 16. The excess length ofconnector 16 may be cut or trimmed using a variety of cutting ortrimming mechanisms. In one method embodiment, the temperature ofproximal anchor 14 is maintained or changed by controlling thetemperature of a liquid such as saline that is brought into contact withproximal anchor 14 by a user. In one embodiment, the lumen of proximalanchor 14 is lined with one or more barbs or projections. The one ormore barbs or projections allow motion of connector 16 through the lumenof proximal anchor 14 in one direction and prevent or substantiallyresist motion of connector 16 through the lumen of proximal anchor 14 inthe opposite direction.

FIG. 4AE shows a cross section of the proximal anchor of FIG. 4ADthrough the line 4AE-4AE when the shape memory material of the proximalanchor is in the martensite phase. In FIG. 4AE, the diameter of thelumen of proximal anchor 14 is larger than the outer diameter ofproximal anchor 14. This allows a user to advance proximal anchor 14over connector 16. FIG. 4AE′ shows a cross section of the proximalanchor of FIG. 4AD through the line 4AE-4AE when the shape memorymaterial of the proximal anchor is in the programmed shape. In FIG.4AE′, the diameter of the lumen of proximal anchor 14 is smaller thanthe outer diameter of proximal anchor 14. This causes a region ofproximal anchor 14 to compress a region of connector 16. This in turncauses proximal anchor 14 to attach to connector 16.

FIG. 4AF shows a cross section of the proximal anchor of FIG. 4ADthrough the line 4AF-4AF when the shape memory material of the proximalanchor is in the martensite phase. In FIG. 4AF, the diameter of thelumen of proximal anchor 14 is larger than the outer diameter of lumenplug 164. FIG. 4AF′ shows a cross section of the proximal anchor of FIG.4AD through the line 4AF-4AF when the shape memory material of theproximal anchor is in the programmed shape. In FIG. 4AF′, the diameterof the lumen of proximal anchor 14 is smaller than the outer diameter oflumen plug 164. This causes lumen plug 164 to substantially plug one endof the lumen of proximal anchor 14.

FIG. 4AG shows a side view of a second embodiment of a proximal anchormade of a thermal shape memory alloy. In FIG. 4AG, proximal anchor 14comprises a hollow elongate body made of a suitable shape memorymaterial. Examples of such shape memory materials include, but are notlimited to nickel-titanium alloys (nickel-titanium alloy (e.g.,nitinol)), copper-aluminum-nickel alloys, copper-zinc-aluminum alloys,iron-manganese-silicon alloys, etc. In the embodiment shown in FIG. 4AG,proximal anchor 14 is made of nickel-titanium alloy (e.g., nitinol).Proximal anchor 14 encloses a lumen. One end of proximal anchor 14 maybe plugged. In the embodiment shown in FIG. 4AG, proximal anchor 14comprises two or more shape memory arms 166. Proximal anchor 14comprises a connector opening 100. A connector 16 enters proximal anchor14 through connector opening 100. Connector 16 exits proximal anchor 14through the region enclosed by shape memory arms 166. A user can controlthe size of the region enclosed by shape memory arms 166 by changing thetemperature of proximal anchor 14. In one embodiment of a method ofanchoring proximal anchor 14 to connector 16, proximal anchor 14 isintroduced in the anatomy in the martensite phase of the shape memorymaterial of shape memory arms 166. The size of the region enclosed byshape memory arms 166 in the martensite state is sufficiently large toallow proximal anchor 14 to be advanced over connector 16. Themartensite phase may be achieved for example, by cooling proximal anchor14 and introducing the cooled proximal anchor 14 in the anatomy. Afterproximal anchor 14 warms up to the body temperature, the shape memorymaterial recovers a programmed shape and becomes super-elastic. In theprogrammed shape, the size of the region enclosed by shape memory arms166 is sufficiently small to cause shape memory arms 166 to compress aregion of connector 16. This causes proximal anchor 14 to attach toconnector 16. The excess length of connector 16 may be cut or trimmedusing a variety of cutting or trimming mechanisms. In one methodembodiment, the temperature of proximal anchor 14 is maintained orchanged by controlling the temperature of a liquid such as saline thatis brought into contact with proximal anchor 14 by a user. In oneembodiment, the lumen of proximal anchor 14 is lined with one or morebarbs or projections. The one or more barbs or projections allow motionof connector 16 through the lumen of proximal anchor 14 in one directionand prevent or substantially resist motion of connector 16 through thelumen of proximal anchor 14 in the opposite direction.

FIG. 4AH shows a cross section of the proximal anchor of FIG. 4AGthrough the line 4AH-4AH when the shape memory material of the proximalanchor is in the martensite phase. In FIG. 4AH, the size of the regionenclosed by shape memory arms 166 is larger than the outer diameter ofproximal anchor 14. This allows a user to advance proximal anchor 14over connector 16. FIG. 4AH′ shows a cross section of the proximalanchor of FIG. 4AG through the line 4AH-4AH when the shape memorymaterial of the proximal anchor is in the programmed shape. In FIG.4AH′, the size of the region enclosed by shape memory arms 166 issmaller than the outer diameter of proximal anchor 14. This causes theregion enclosed by shape memory arms 166 to compress a region ofconnector 16. This in turn causes proximal anchor 14 to attach toconnector 16.

FIGS. 4AI and 4AJ show longitudinal sections of an embodiment of aproximal anchor showing the steps of an embodiment of a method ofanchoring a looped or folded region of the connector to the proximalanchor. Proximal anchor 14 comprises a hollow elongate body. A pull wire168 passes through the hollow proximal anchor 14. Pull wire 168 loopsaround connector 16 and reenters proximal anchor 14 as shown in FIG.4AI. Thus, the loop of pull wire 168 pulls connector 16 towards proximalanchor 14. In FIG. 4AI, the loop of pull wire 168 is advanced overconnector 16. This causes proximal anchor 14 to be advanced overconnector 16. Proximal anchor 14 is advanced to position proximal anchor14 in a desired location. In the step shown in FIG. 4V, pull wire 168 ispulled by a user. This pulls a loop of connector 16 inside proximalanchor 14. The loop of connector 16 pulled inside proximal anchor 14wedges inside the lumen of proximal anchor 14. This in turn causesconnector 16 to attach to proximal anchor 14. The excess length ofconnector 16 and/or pull wire 168 may be cut or trimmed using a varietyof cutting or trimming mechanisms.

FIG. 4AK shows a side view of an embodiment of a proximal anchor made ofa suitable elastic or super elastic or shape memory material comprisingone or more inwardly opening flaps. In FIG. 4AK, proximal anchor 14comprises a hollow tubular body. The hollow tubular body is made of asuitable elastic or super elastic or shape memory material. Examples ofsuch materials include, but are not limited to metals such asnickel-titanium alloy (e.g., nitinol), stainless steel, titanium, etc.and polymers such as shape memory polymers, etc. The tubular bodycomprises one or more inwardly opening flaps 20. In the embodiment shownin FIG. 4AK, inwardly opening flaps 20 are oriented along the axis ofproximal anchor 14. Inwardly opening flaps 20 allow the motion of aconnector 16 that passes through proximal anchor 14 along the directionof orientation of inwardly opening flaps 20. Also, inwardly openingflaps 20 prevent the motion of connector 16 that passes through proximalanchor 14 along the direction opposite to the direction of orientationof inwardly opening flaps 20. This enables proximal anchor 14 to beadvanced over connector 16 along one direction. In one embodiment,proximal anchor 14 is made of an elastic or super elastic material. Inthis embodiment, proximal anchor 14 is introduced in the anatomy bysliding proximal anchor 14 over connector 16 in the direction oforientation of inwardly opening flaps 106. Proximal anchor 14 isadvanced over connector 16 till proximal anchor 14 is located in adesired location. Inwardly opening flaps 106 prevent the motion ofproximal anchor 106 connector 16 in the direction opposite to thedirection of orientation of inwardly opening flaps 106. In anotherembodiment, proximal anchor 14 is made of a shape memory material suchas nickel-titanium alloy (e.g., nitinol). In this embodiment, proximalanchor 14 is introduced in the anatomy in the martensite phase ofnickel-titanium alloy (e.g., nitinol). In this state, inwardly openingflaps 20 are aligned substantially parallel to the surface of proximalanchor 14. This allows proximal anchor 14 to be advanced over connector16. The martensite phase may be achieved, for example, by coolingproximal anchor 14 and introducing the cooled proximal anchor 14 in theanatomy. After proximal anchor 14 warms up to the body temperature, thenickel-titanium alloy (e.g., nitinol) recovers a programmed shape andbecomes super-elastic. In the programmed shape, inwardly opening flaps20 are bent inwards into the lumen of proximal anchor 14. This attachesproximal anchor 14 to connector 16.

FIG. 4AL shows a longitudinal section through the embodiment of theproximal anchor of FIG. 4AK. Proximal anchor 14 comprises a hollowtubular body comprising one or more inwardly opening flaps 20. Inwardlyopening flaps 20 prevent the motion of connector 16 along the directionopposite to the direction of orientation of inwardly opening flaps 20.

In an alternate embodiment, proximal anchor 14 is attached to connector16 using a biocompatible adhesive. The biocompatible adhesive may beintroduced by a suitable proximal anchor delivery device 34 thatcomprises an adhesive injecting tube. In one embodiment of a method ofattaching proximal anchor 14 to connector 16, proximal anchor 14 ispositioned at a desired location relative to connector 16. A suitablebiocompatible adhesive is introduced such that the adhesive attachesproximal anchor 14 to a location on connector 16. In one embodiment, theadhesive is introduced through a lumen in actuator 120.

FIG. 5A shows a side view of a first embodiment of a proximal anchordelivery device comprising one or more finger activated triggers. Theembodiment of proximal anchor delivery device 34 shown in FIG. 5Acomprises an elongate endoscope channel 170. Elongate endoscope channel170 may be made of suitable biocompatible materials. Examples of suchmaterials include, but not limited to polymers e.g. polyester,polyimide, PEEK, polyurethane, polysulfone, polyetherimides,polycarbonate, and may be filled with glass or reinforcing fiber, etc;metals e.g. stainless steel, titanium, etc. In one embodiment, endoscopechannel 170 is made of 316 stainless steel. The proximal end ofendoscope channel 170 comprises an endoscope adapter hub 172. Endoscopeadapter hub 172 allows a user to introduce an endoscope through theproximal end of endoscope channel 170. The proximal region of endoscopechannel 170 is attached to a handle 174. Proximal anchor delivery device34 further comprises an elongate anchor tube 176. Anchor tube 176 may bemade of suitable biocompatible materials. Examples of such materialsinclude, but not limited to polymers e.g. polyester, polyimide, PEEK,polyurethane, polysulfone, polyetherimides, polycarbonate, and may befilled with glass or reinforcing fiber, etc. metals e.g. stainlesssteel, titanium, nickel-titanium alloy (e.g., nitinol), etc. In oneembodiment, anchor tube 176 is made of 316 stainless steel. The distalend of anchor tube 176 may comprise a blunt or atraumatic tip. Anchortube 176 is attached to endoscope channel 170 such that anchor tube 176is substantially parallel to endoscope channel 170 as shown in FIG. 5A.Anchor tube 176 comprises a lumen that encloses proximal anchor 14.Proximal anchor 14 is deployed in the anatomy through the distal regionof anchor tube 176. The distal region of anchor tube 176 may comprise abent, curved or angled region. Proximal anchor delivery device 34 isused to attach a proximal anchor 14 to a desired location on a connector16. A suitable tension may be introduced into connector 16 before thestep of attaching proximal anchor 14 to connector 16. In order tointroduce this desired tension, proximal anchor delivery device 34further comprises a tensioning mechanism. In the embodiment shown inFIG. 5A, the tensioning mechanism comprises a pulling mechanism. Thepulling mechanism pulls connector 16 between a sliding rack 178 and asuture trap 180. Suture trap 180 is hinged to sliding rack 178 as shownin FIG. 5A. Sliding rack 178 moves on a sliding slot 182 located onhandle 174. In one embodiment, various components of the pullingmechanism are constructed from stainless steel 304 and nickel-titaniumalloy (e.g., nitinol). The step of moving sliding rack 178 on slidingslot 182 is performed by pulling a first trigger 184 attached to handle174. Handle 174 may comprise a first trigger safety 186 to preventunwanted movement of first trigger 184. After a desired tension has beencreated in connector 16, proximal anchor 14 may be deployed in theanatomy by a second trigger 188. In the embodiment shown in FIG. 5A,second trigger 188 comprises an elongate lever. One end of the elongatelever is hinged to handle 174. The other end of elongate lever ispivotally attached to an actuator block 190. Actuator block 190 slidesover the outer surface of endoscope channel 170. Actuator block 190 isconnected to an elongate actuator. The movement of the elongate actuatorcuts connector 16 and also attaches proximal anchor 14 to connector 16.Handle 174 may comprise a second trigger safety 192 to prevent unwantedmovement of second trigger 188.

In the embodiment shown in FIG. 5A, a portion of connector 16 passesthrough anchor tube 176. In an alternate embodiment, proximal anchordelivery device 34 further comprises an elongate suture tube. The suturetube is attached to the outer surface of endoscope channel 170. Thedistal end of the suture tube is attached to anchor tube 176 aroundsecond anchor tube opening 196 such that connector 16 emerges out ofsecond anchor tube opening 196 and passes through the suture tube.Connector 16 emerges out of the proximal end of the suture tube andfurther passes through the tensioning mechanism.

In one embodiment, proximal anchor delivery device 34 is sized to beintroduced through a 25F cystoscope sheath. The length of proximalanchor delivery device 34 within the sheath ranges from 6 to 14 inches.In this embodiment, endoscope channel 170 and endoscope adapter hub 172are designed to fit a 4 mm telescope. In this embodiment, the outerdiameter of endoscope channel 170 ranges from 0.174 to 0.200 inches andthe inner diameter of endoscope channel 170 ranges from 0.160 to 0.180inches. In this embodiment, the outer diameter of anchor tube 176 rangesfrom 0.050 to 0.072 inches and the inner diameter of anchor tube 176ranges from 0.030 to 0.063 inches. In this embodiment, the maximumdistance through which the actuator travels ranges from 0.060 to 0.300inches. In a preferred embodiment, proximal anchor delivery device 34 issized to be introduced through a 25F cystoscope sheath. The length ofproximal anchor delivery device 34 within the sheath ranges from isapproximately 10 inches. In this preferred embodiment, endoscope channel170 and endoscope adapter hub 172 are designed to fit a Storz 4 mmtelescope. In this preferred embodiment, the outer diameter of endoscopechannel 170 is approximately 0.180 inches and the inner diameter ofendoscope channel 170 is approximately 0.160 inches. In this preferredembodiment, the outer diameter of anchor tube 176 is approximately 0.059inches and the inner diameter of anchor tube 176 is approximately 0.046inches. In this preferred embodiment, the maximum distance through whichthe actuator travels is approximately 0.240 inches.

FIGS. 5B through 5D show longitudinal sections through the distal tip ofthe proximal anchor delivery device of FIG. 5A showing the steps of amethod of deploying a proximal anchor in the anatomy. In the step shownin FIG. 5B, proximal anchor 14 is enclosed in the distal region ofanchor tube 176. In the embodiment shown in FIG. 5B, anchor tube 176comprises a first anchor tube opening 194 and a second anchor tubeopening 196. Connector 16 enters anchor tube 176 through first anchortube opening 194. Connector 16 passes through proximal anchor 14 andemerges out of anchor tube 176 through second anchor tube opening 196.In the embodiment shown in FIG. 5B, proximal anchor 14 comprises ahollow tube. Proximal anchor 14 comprises a locking crimp 103. Thehollow tube further comprises a connector opening 100 located roughlymidway between the ends of the tube. One edge of connector opening 100is lined with an outwardly opening flap 26. Outwardly opening flap 26 isfolded as shown in FIG. 5B to create a blunt edge to connector opening100. The opposite edge of connector opening comprises a second lockingtab 198. Second locking tab 198 is made by cutting a flap in thematerial of proximal anchor 14 and bending the flap into the lumen ofproximal anchor 14 as shown. Connector 16 is locked to proximal anchor14 by driving a lock pin 104 into proximal anchor 14. In FIG. 5B, lockpin 104 is partially inserted into proximal anchor 14 such that thelength of the combination of lock pin 104 and proximal anchor 14 is morethan the length of first anchor tube opening 194. This prevents unwantedseparation of proximal anchor 14 from anchor tube 176 through secondanchor tube opening 196. In the embodiment shown in FIG. 5B, lock pin104 comprises a locking slot 106. Locking slot 106 allows lock pin 104to lock to proximal anchor 14 by locking crimp 103. Lock pin 104 furthercomprises a second locking slot 200. In one embodiment, the distancefrom locking slot 106 to second locking slot 200 along the length oflock pin 104 is the same as the distance from second locking tab 198 tolocking crimp 103 along the length of proximal anchor 14. In anotherembodiment, the distance from locking slot 106 to second locking slot200 along the length of lock pin 104 is slightly more than the distancefrom second locking tab 198 to locking crimp 103 along the length ofproximal anchor 14. In a preferred embodiment, proximal anchor 14 andlock pin 104 are made of stainless steel 316L. In the preferredembodiment, tube 24 is laser cut and then electropolished. Lock pin 104is constructed using EDM (electrical discharge machining) and thenpassivated. The geometries of proximal anchor 14, connector 16 and lockpin 104 enable lock pin 104 to lock connector 16 to proximal anchor 14.In a preferred embodiment, the length of proximal anchor 14 is 0.236inches, the outer diameter of proximal anchor 14 is 0.027 inches, theinner diameter of proximal anchor 14 is 0.020 inches, the length of lockpin 104 is 0.236 inches and the outer diameter of lock pin 104 is 0.019inches.

In the embodiment shown in FIG. 5B, lock pin 104 is driven into proximalanchor 14 by an actuator 120. In the embodiment shown in FIG. 5B,actuator 120 comprises a bent distal tip. The bent distal tip forms adistal edge that is in contact with the distal end of lock pin 104.Actuator 120 further comprises an actuator opening 202. The distal edgeof actuator opening 202 may be sharpened. Actuator opening 202 islocated near second anchor tube opening 196 such that connector 16passes through both actuator opening 202 and second anchor tube opening196. In the step shown in FIG. 5B, a desired tension is created inconnector 16.

In the step shown in FIG. 5C, actuator 120 is pulled in the proximaldirection by a user. This causes the bent distal tip of actuator 120 todrive lock pin 104 towards proximal anchor 14. This in turn causeslocking crimp 103 to unlock from locking slot 106. Lock pin 104 thenmoves in the proximal direction till locking crimp 103 locks into secondlocking slot 200 and second locking tab 198 locks into locking slot 106.This causes lock pin 104 to lock to proximal anchor 14. In thisconfiguration, lock pin is inserted into proximal anchor 14 such thatthe length of the combination of lock pin 104 and proximal anchor 14 issmaller than the length of first anchor tube opening 194. The movementof lock pin 104 along the proximal direction further causes the proximaltapering end of lock pin 104 to wedge between proximal anchor 14 andconnector 16. Thus, proximal anchor 14 is locked to connector 16.Further, pulling actuator 120 in the proximal direction causes connector16 to get sheared between the edges of actuator opening 202 and secondanchor tube opening 196. This cuts connector 16.

In the step shown in FIG. 5D, proximal anchor 14 is pulled by thetension in connector 16. Since the length of the combination of lock pin104 and proximal anchor 14 is less than the length of first anchor tubeopening 194, proximal anchor 14 emerges out of anchor tube 176 throughfirst anchor tube opening 194. Thus, proximal anchor 14 is deployed inthe anatomy.

FIG. 5E shows a side view of a proximal anchor similar to the proximalanchor in FIGS. 5B-5D having an undeployed lock pin partially insertedinto the proximal anchor.

FIGS. 5F through 5H show longitudinal sections through the proximalanchor and the lock pin of FIG. 5E showing the steps of a method ofattaching the proximal anchor to a connector using the lock pin. In FIG.5E, proximal anchor 14 comprises locking tab 102 and second locking tab198. Lock pin 104 comprises locking slot 106 and second locking slot200. In FIG. 5E, locking tab 102 of proximal anchor 14 locks intolocking slot 106 on lock pin 104. Thus lock pin 104 is temporarilylocked to proximal anchor 14 in an undeployed configuration. In the stepshown in FIG. 5G, connector 16 is passed through proximal anchor 14. Inthe embodiment shown in FIG. 5G, connector 16 enters proximal anchor 14through connector opening 100 and exits proximal anchor 14 through theproximal end of proximal anchor 14. In the step shown in FIG. 5H, lockpin 104 is moved by a user along the proximal direction into proximalanchor 14. Lock pin 104 is moved until locking tab 102 locks into secondlocking slot 200 and second locking tab 198 locks into locking slot 106.This causes lock pin 104 to lock to proximal anchor 14. Also, theproximal tapering end of lock pin 104 wedges between proximal anchor 14and connector 16. Thus, proximal anchor 14 is attached to connector 16.The excess length of connector 16 may be cut or trimmed.

Several embodiments of lock pin 104 may be used to lock connector 16 toproximal anchor 14. FIG. 5I shows a side view of an embodiment of a lockpin that can be used to lock connector 16 to proximal anchor 14 as shownin the method of FIGS. 5B-5D. In the embodiment shown in FIG. 5I, lockpin 104 is made from a cylinder of suitable biocompatible material.Examples of such biocompatible materials include, but are not limited tometals e.g. nickel-titanium alloy (e.g., nitinol), stainless steel,titanium, etc. or polymers e.g. EXAMPLES, etc. Lock pin 104 comprises alocking slot 106. Locking slot 106 allows lock pin 104 to lock tolocking tab 102 of proximal anchor 14. Lock pin 104 further comprises asecond locking slot 200 distal to locking slot 106. Lock pin 104 furthercomprises a tapering region proximal to locking slot 106. The taperingregion acts as a wedge between the internal surface of proximal anchor14 and connector 16, thereby locking connector 16 to proximal anchor 14.In one embodiment, the total length of lock pin 104 is about 0.236inches. In this embodiment, lock pin 104 is made from a cylinder ofstainless steel 316L of a diameter about 0.019 inches. In thisembodiment, the length from the proximal tip of lock pin 104 to theproximal edge of locking slot 106 is about 0.122 inches. In thisembodiment, the length from the proximal tip of lock pin 104 to theproximal edge of second locking slot 200 is about 0.206 inches. In oneembodiment of a method for manufacturing lock pin 104, lock pin 104 ismade by laser cutting a cylinder of a suitable biocompatible material.

FIG. 5J shows another side view of the lock pin of connector shown inFIG. 5I.

Several embodiments of actuator 120 may be used to drive lock pin 104into proximal anchor 14 to lock connector 16 to proximal anchor 14. FIG.5K shows an isometric view of an embodiment of an actuator 120 that canbe used to drive lock pin 104 into proximal anchor 14. In the embodimentshown in FIG. 5K, actuator 120 comprises an elongate cylindrical orflattened pull rod 203. The proximal region of pull rod 203 is enlargedas shown in FIG. 5K. The distal region of actuator 120 comprises twoprojections: a proximal projection 204 and a distal projection 206.Proximal projection 204 and distal projection 206 are used totemporarily hold proximal anchor 14 between them. The region of actuator120 between proximal projection 204 and a distal projection 206comprises actuator opening 202.

FIG. 5L shows a side view of the embodiment of the actuator shown inFIG. 5K. FIG. 5L shows actuator 120 comprising proximal projection 204and distal projection 206. The region of actuator 120 between proximalanchor 14 and a distal projection 206 comprises actuator opening 202.

FIG. 5M shows a longitudinal section through the actuator of FIG. 5L.The distal edge of actuator opening 202 is sharpened to form an actuatorcutting edge 208. In the embodiment shown in FIG. 5M, the angle betweenactuator cutting edge 208 and the longitudinal axis of actuator 120 isabout 45 degrees. In one embodiment, the total length of actuator 120 is14 inches. The distance between the proximal edge of distal projection206 and the distalmost region of proximal projection 204 is about 0.373inches. In this embodiment, the length from the distal end of theenlarged proximal region of pull rod 203 to the distal end of actuator120 is about 1.49 inches.

FIG. 5N shows a side view of a second embodiment of a proximal anchordelivery device 34. Proximal anchor delivery device 34 comprises anendoscope introducing tube 48. The proximal end of endoscope introducingtube 48 may comprise an endoscope hub 50 to lock an endoscope 74 toendoscope introducing tube 48. Endoscope introducing tube 48 encloses alumen through which a suitable endoscope 74 may be introduced into theanatomy. Proximal anchor delivery device 34 comprises an anchor tube176. The distal end of the anchor tube 176 comprises first anchor tubeopening 194 and second anchor tube opening 196 such as shown in FIG. 5B.The lumen of anchor tube 176 encloses a proximal anchor 14 held by anactuator 120. Actuator 120 is used to deploy proximal anchor 14 out ofthe distal region of anchor tube 176 and into the anatomy by a methodsimilar to the method shown in FIGS. 5B-5D. Deployment of proximalanchor 14 in the anatomy is visualized by an endoscope 74 that isintroduced through endoscope introducing tube 48 such that the distalend of anchor tube 176 is located near the distal end of endoscope 74.The distal end of anchor tube 176 may comprise a curved, bent or taperedregion. Anchor tube 176 is attached to endoscope introducing tube 48 bya coupling element 76. Proximal anchor delivery device 34 may beintroduced into the anatomy through a suitable sheath. Such as sheathmay comprise a flushing or aspiration port. The flushing or aspirationport may be in fluid communication with the lumen of the sheath to allowa user to introduce fluids into or remove fluids from an anatomicalregion.

The embodiment of proximal anchor delivery device 34 shown in FIG. 5Nmay be used to introduce a proximal anchor 14 over a connector 16 intothe anatomy. Proximal anchor 14 is attached to connector 16 and theexcess length of connector is trimmed. For example, FIGS. 5O through 5Sshow the steps of an embodiment of a method of deploying an anchor in ananatomical region using proximal anchor delivery device 34 of FIG. 5N.In the step shown in FIG. 5O, a distal anchor 12 attached to a connector16 has been anchored in the anatomy. In one method embodiment, distalanchor 12 is anchored transurethrally near the prostate gland capsule bythe method shown in FIGS. 3M through 3T. In this embodiment, distalanchor 12 is anchored by one or more devices inserted through a sheath28 inserted in the urethra. After performing this step, the one or moredevices are removed leaving sheath 28 in the urethra.

In the step shown in FIG. 5P, connector 16 is inserted into an openingin the distal region of anchor tube 176. Connector 16 is passed throughproximal anchor 14 enclosed by anchor tube 176. Connector 16 is removedfrom the proximal region of anchor tube 176. Proximal anchor deliverydevice 34 is inserted in sheath 28 over connector 16 such that thedistal end of anchor tube 176 emerges out of the distal end of sheath28.

In the step shown in FIG. 5Q, proximal anchor 14 is attached toconnector 16. Also, the excess length of connector 16 is trimmed. Thismay be done for example, by a mechanism similar to the mechanism shownin FIGS. 5B through 5D. Thus, proximal anchor 14 is released from anchortube 168 and is deployed in the anatomy as shown in FIG. 5Q. In onemethod embodiment, proximal anchor 14 is deployed in the region of theurethra enclosed by the prostate gland.

In the step shown in FIG. 5R, proximal anchor delivery device 34 andendoscope 74 are removed from sheath 28.

In the step shown in FIG. 5S, sheath 28 is removed from the anatomyleaving behind proximal anchor 14 and distal anchor 12 connected byconnector 16.

The distal ends of the various proximal anchor delivery devices 34 maybe bent, curved, angled, or shaped to deliver a proximal anchor 14 at anangle to the axis of proximal anchor delivery device 34. For example,FIG. 5T shows the distal end of an embodiment of a proximal anchordelivery device comprising an anchor tube with a bent, curved or angleddistal end. Proximal anchor delivery device 34 in FIG. 5T is introducedin the anatomy through a sheath 28. Proximal anchor delivery device 34comprises anchor tube 176 with a bent, curved or angled distal end. Thebent, curved or angled distal end of anchor tube 176 enables a user todeploy a proximal anchor 14 in the anatomy at an angle to the axis ofproximal anchor delivery device 34.

FIG. 5U shows the step of deploying a proximal anchor in an anatomicalregion by the proximal anchor delivery device of FIG. 5T. In the stepshown in FIG. 5U, proximal anchor 14 is being deployed in the anatomy atan angle to the axis of proximal anchor delivery device 34.

The various mechanisms of deploying proximal or distal anchor disclosedherein may be used to design various embodiments of proximal and distalanchor delivery devices. For example, mechanisms of deploying a distalanchor similar to the mechanism shown in FIGS. 3D through 3K may be usedto design several embodiments of distal anchor deploying devices.Similarly, mechanisms of deploying a proximal anchor similar to themechanism shown in FIGS. 5B through 5D may be used to design severalembodiments of proximal anchor deploying devices.

Pre-Clinical Testing:

Pre-clinical testing of an embodiment of a method of compressing aregion of the prostate gland was done to evaluate the safety aspects ofthe method. The devices shown in FIGS. 3A and 5A were used to deploy theretractor 10 shown in FIG. 1C in the prostate gland of the dogs. Sixmongrel dogs of 27 to 35 kg underwent a transurethral procedure forluminal restoration of the urethral region enclosed by the prostategland. In each animal a single retractor 10 was deployed. All procedureswere successful with no adverse events. The total procedure time fromthe time sheath 28 was introduced transurethrally until the time thesheath 28 was removed ranged from 27 to 55 minutes. All the animals werefollowed up cystoscopically. Typical acute results are shown in FIG. 5V.FIG. 5V shows a cystoscopic view of a region of canine urethra enclosedby the prostate gland that has been treated by a procedure similar tothe procedure shown in FIGS. 1D through 1J. FIG. 5V shows a proximalanchor 14 of a retractor 10 shown in FIG. 1C. Retractor 10 is used tocompress a region of the prostate gland.

FIG. 6A shows a side view of an embodiment of a distal anchor deliverydevice. In the embodiment shown in FIG. 6A, distal anchor deliverydevice 30 comprises an elongate puncturing element e.g. a needle 32 thatcomprises a lumen. The proximal end of needle 32 is connected to ahandle 174. In the embodiment shown in FIG. 6A, handle 174 comprises acurved handpiece that can be gripped by a user with one hand. Anelongate pusher 64 slides through the lumen of needle 32. The proximalend of pusher 64 may be enlarged to allow the user to push pusher 64with the other hand. When pusher 64 is pushed by the user, a distalanchor 12 attached to a connector 16 is pushed out of the distal end ofneedle 32.

FIG. 6B shows an enlarged view of the distal region of the distal anchordelivery device of FIG. 6A showing the step of deploying a distal anchorby the distal anchor delivery device. In one method embodiment ofdeploying a distal anchor 12, distal anchor delivery device 30 is pushedinto the anatomy until the distal tip of needle 32 is in a desiredlocation. Pusher 64 is pushed by a user. This causes the distal tip ofpusher 64 to push a distal anchor 12 attached to a connector 16 out ofthe distal end of needle 32. Distal anchor delivery device 30 is removedfrom the anatomy by sliding distal anchor delivery device 30 overconnector 16. A desired tension may be generated in connector 16 and aproximal anchor 14 attached to connector 16 to hold and/or compress ananatomical region between proximal anchor 14 and distal anchor 12.

FIG. 6C shows a side view of an embodiment of a proximal anchor deliverydevice. The embodiment of proximal anchor delivery device 34 shown inFIG. 6C may be used to generate a desired tension in connector 16 andattach a proximal anchor 14 to connector 16 after the step shown in FIG.6B. In the embodiment shown in FIG. 6C, proximal anchor delivery device34 comprises an elongate anchor tube 176 that comprises a lumen. In theembodiment shown, the distal tip of anchor tube 176 comprises a bent,curved or angled region. The proximal end of anchor tube 176 isconnected to a handle 174. In the embodiment shown in FIG. 6C, handle174 comprises a curved handpiece that can be gripped by a user with onehand. An elongate actuator 120 slides through the lumen of anchor tube176. The proximal end of actuator 120 may be enlarged to allow the userto pull actuator 120 with the other hand. When actuator 120 is pulled bythe user, a proximal anchor 14 is attached to a connector 16. Also, whenactuator 120 is pulled by the user, the excess length of connector 16may be cut or trimmed by a mechanism similar to the mechanism shown inFIGS. 5B through 5D.

FIG. 6D shows an enlarged view of the distal region of the proximalanchor delivery device of FIG. 6C. In one embodiment of a method ofdeploying a proximal anchor 14, proximal anchor delivery device 34 ofFIG. 6C is inserted in the anatomy over connector 16. This is done suchthat connector 16 passes through a proximal anchor 14 located in anchortube 176. Proximal anchor delivery device 34 is advanced in the anatomyuntil the distal tip of anchor tube 176 is in a desired location.Connector 16 is pulled by a user to introduce a desired tension inconnector 16. Actuator 120 is pulled by a user. This attaches proximalanchor 14 to connector 16 by a mechanism similar to the mechanism shownin FIGS. 5B through 5D. Also, the excess length of connector 16 may becut or trimmed by a mechanism similar to the mechanism shown in FIGS. 5Bthrough 5D. Distal anchor delivery device 30 is removed from theanatomy. This step leaves behind proximal anchor 14 and distal anchor 12connected to each other by connector 16.

The anchor delivery devices disclosed herein may be used to bury ananchor within an anatomical tissue. For example, FIG. 6E shows thedistal region of an embodiment of a proximal anchor delivery devicecomprising a curved penetrating distal tip. In the embodiment shown inFIG. 6E, proximal anchor delivery device 34 comprises an anchor tube 176with a curved penetrating distal tip. The penetrating distal tip is usedto penetrate an anatomical tissue. A proximal anchor 14 is deployedwithin the anatomical tissue, thereby burying proximal anchor 14 withinthe anatomical tissue.

FIG. 6F shows an embodiment of a retractor comprising a proximal anchorburied within an anatomical tissue by the proximal anchor deliverydevice of FIG. 6E. In one method embodiment, a distal anchor 12 attachedto a connector 16 is deployed in the anatomy. Proximal anchor deliverydevice 34 is inserted in the anatomy over connector 16. This is donesuch that connector 16 passes through a proximal anchor 14 located inanchor tube 176. Proximal anchor delivery device 34 is advanced in theanatomy such that the curved distal tip of anchor tube 176 tangentiallypenetrates a wall of an anatomical tissue. Proximal anchor deliverydevice 34 is advanced until the curved distal tip of anchor tube 176 isin a desired location. Connector 16 is pulled by a user to introduce adesired tension in connector 16. Proximal anchor 14 is attached toconnector 16. This may be done by a mechanism on proximal anchordelivery device 34 similar to the mechanism shown in FIGS. 5B through5D. Also, the excess length of connector 16 may be cut or trimmed. Thismay be done by a mechanism on proximal anchor delivery device 34 similarto the mechanism shown in FIGS. 5B through 5D. Distal anchor deliverydevice 30 is removed from the anatomy. This step leaves behind proximalanchor 14 buried within the anatomical tissue connected to distal anchor12 by connector 16.

FIG. 6G shows the distal region of an embodiment of a proximal anchordelivery device comprising a straight penetrating distal tip. In theembodiment shown in FIG. 6G, proximal anchor delivery device 34comprises an anchor tube 176 with a straight penetrating distal tip. Thepenetrating tip is used to penetrate an anatomical tissue. A proximalanchor 14 is deployed within the anatomical tissue, thereby buryingproximal anchor 14 within the anatomical tissue.

FIG. 6H shows an embodiment of a retractor comprising a proximal anchorburied within an anatomical tissue by the proximal anchor deliverydevice of FIG. 6G. In one method embodiment, a distal anchor 12 attachedto a connector 16 is deployed in the anatomy. Proximal anchor deliverydevice 34 is inserted in the anatomy over connector 16. This is donesuch that connector 16 passes through a proximal anchor 14 located inanchor tube 176. Proximal anchor delivery device 34 is advanced in theanatomy such that the straight distal tip of anchor tube 176 penetratesa wall of an anatomical tissue roughly perpendicular to the wall of ananatomical tissue. Proximal anchor delivery device 34 is advanced untilthe straight distal tip of anchor tube 176 is in a desired location.Connector 16 is pulled by a user to introduce a desired tension inconnector 16. Proximal anchor 14 is attached to connector 16. This maybe done by a mechanism on proximal anchor delivery device 34 similar tothe mechanism shown in FIGS. 5B through 5D. Also, the excess length ofconnector 16 may be cut or trimmed. This may be done by a mechanism onproximal anchor delivery device 34 similar to the mechanism shown inFIGS. 5B through 5D. Distal anchor delivery device 30 is removed fromthe anatomy. This step leaves behind proximal anchor 14 buried withinthe anatomical tissue connected to distal anchor 12 by connector 16. Thetension in connector 16 may cause proximal anchor 14 to flip and orientperpendicularly to connector 16.

Various embodiments of distal anchor delivery device 30 and variousembodiments of proximal anchor delivery device 34 may be combined into asingle device that delivers both distal anchor 12 and proximal anchor14. For example, FIG. 6I shows a section through the distal tip of afirst embodiment of a combined device that can deliver a distal anchorconnected to a proximal anchor by a connector. In FIG. 6I, a combineddevice 210 is introduced in the anatomy through an elongate sheath 28.The distal tip of combined device 210 comprises an arrangement to hold aproximal anchor 14. Proximal anchor 14 may be controllably deliveredfrom combined device 210 by a user into the anatomy by a releasingmechanism. Proximal anchor 14 is connected to a connector 16. Connector16 is further connected to a distal anchor 12. Distal anchor 12 isattached to a distal region of combined device 210 by an arrangement tohold distal anchor 12. Distal anchor 12 may be controllably deliveredfrom combined device 210 by the user into the anatomy by a releasingmechanism. The step of delivering proximal anchor 14 and/or the step ofdelivering distal anchor 12 may be visualized by an endoscope 74.

FIG. 6J shows a side view of a second embodiment of a combined devicethat can deliver a distal anchor and a proximal anchor connected to eachother by a connector. In FIG. 6J, combined device 210 comprises anelongate anchor tube 176 through which proximal anchor 14 and distalanchor 12 are delivered. Combined device 210 further comprises anarrangement for introducing an endoscope 74. The step of deliveringproximal anchor 14 and/or the step of delivering distal anchor 12 may bevisualized by endoscope 74. Combined device 210 further comprises ahandle 174 to enable a user to hold combined device 210. Proximal anchor14 and distal anchor 12 are delivered in the anatomy by moving an anchordelivery trigger 216 connected to handle 174. In a distal anchordelivery mode, anchor delivery trigger 216 is used to deliver distalanchor 12. In a proximal anchor delivery mode, anchor delivery trigger216 is used to deliver proximal anchor 14. In one embodiment, movementof anchor delivery trigger 216 causes movement of a needle in the distalanchor delivery mode. A distal anchor 12 is delivered through the needlein the anatomy. In one embodiment, movement of anchor delivery trigger216 locks a proximal anchor 14 connector 106. Also, movement of anchordelivery trigger 216 cuts excess length of a connector 16 attached toproximal anchor 14. This delivers proximal anchor 14 in the anatomy.Anchor delivery trigger 216 is switched between distal anchor deliverymode and proximal anchor delivery mode by a mode selecting switch 218.

FIG. 6K shows a side view of a third embodiment of a combined devicethat can deliver a distal anchor and a proximal anchor connected to eachother by a connector. In this embodiment, combined device 210 furthercomprises a deflecting lever 212 that can be used to controllably bendor deflect the distal region of combined device 210.

In one method embodiment, a combined device is used to deliver a firstanchor to a region distal to a tissue and deliver a second anchor to aregion proximal to the tissue. In another method embodiment, a combineddevice is used to deliver a first anchor to a region proximal to atissue and deliver a second anchor to a region distal to the tissue. Forexample, FIGS. 6L through 6Q show the steps of a method of compressingan anatomical tissue by a combined device that delivers proximal anchor14 and distal anchor 12 in the anatomy. In the step shown in FIG. 6L, acombined device 210 is introduced in the anatomy. Combined device 210comprises a sharp distal end to penetrate anatomical tissue. Combineddevice 210 is advanced through the anatomy until the distal tip ofcombined device 210 is located in a desired location proximal to atissue. Distal anchor 12 is delivered by combined device 210 to thedesired location proximal to a tissue. In the step shown in FIG. 6M,combined device 210 is advanced such that the sharp distal tip ofcombined device 210 penetrates through the tissue. Combined device 210is advanced through the tissue until the distal tip of combined device210 is located in a desired location distal to the tissue. In the stepshown in FIG. 6N, a proximal anchor 14 is delivered by combined device210 to the desired location distal to the tissue. Proximal anchor 14 isconnected to distal anchor 12 by a connector 16 that is attached todistal anchor 12 and passes through proximal anchor 14. Proximal anchor14 comprises a unidirectional mechanism to allow the motion of connector16 through proximal anchor 14 only in one direction. The unidirectionalmechanism prevents the motion of connector 16 through proximal anchor 14in the opposite direction. In the step shown in FIG. 6O, combined device210 is pulled in the proximal direction to partially withdraw combineddevice 210 from the tissue. In the step shown in FIG. 6P, connector 16is pulled with a sufficient force to move connector 16 through proximalanchor 14. This step pulls distal anchor 12 towards proximal anchor 14thereby compressing the tissue between proximal anchor 14 and distalanchor 12. In the step shown in FIG. 6Q, connector 16 is cut. This stepmay be performed by a cutting mechanism in combined device 210 or by aseparate cutter device disclosed elsewhere in this patent application orin the documents incorporated herein by reference. After connector 16 iscut, the unidirectional mechanism on proximal anchor 14 prevents motionof connector 16 through proximal anchor 14. This in turn maintains thetension in connector 16 between proximal anchor 14 and distal anchor 12.

FIGS. 6R through 6W show the distal region of an embodiment of acombined device showing the steps of a method of delivering a retractorcomprising a proximal anchor and a distal anchor, wherein the distalanchor is delivered through the proximal anchor. In the step shown inFIG. 6R, a combined device 210 is introduced in the anatomy. In onemethod embodiment, combined device 210 is inserted trans-urethrally intothe region of the urethra enclosed by the prostate gland. In otheralternate method embodiments, combined device 210 may be introduced intoanatomical regions including, but not limited to large intestines,stomach, esophagus, trachea, a bronchus, bronchial passageways, veins,arteries, lymph vessels, a ureter, bladder, cardiac atria or ventricles,etc. In the embodiment shown in FIG. 6R, the distal region of combineddevice 210 encloses an elongate actuator 120. A surface of actuator 120can be used to drive a lock pin 104 into a proximal anchor 14. Themovement of proximal anchor 14 along the proximal direction isrestricted by a stopper 140. A needle 32 passes through proximal anchor14. In the embodiment shown in FIG. 6R, needle 32 enters proximal anchor14 through the proximal end of proximal anchor 14. Needle 32 exitsproximal anchor 14 through a side opening in proximal anchor 14. In thestep shown in FIG. 6S, needle 32 is advanced through proximal anchor 14such that the distal tip of needle 32 exits combined device 210. Needle32 is advanced further such that needle 32 penetrates through a targettissue TT. In the step shown in FIG. 6T, a distal anchor 12 is deliveredthrough needle 32. Distal anchor 12 is connected to a connector 16 thatpasses through needle 32. In the step shown in FIG. 6U, needle 32 iswithdrawn from combined device 210. This step leaves behind distalanchor 12 connected to connector 16. Connector 16 is pulled in theproximal direction. This step orients distal anchor 12 perpendicular toconnector 16. Also, this step causes a region of the target tissue to becompressed between combined device 210 and distal anchor 12. In the stepshown in FIG. 6V, actuator 120 is pulled in the proximal direction by auser. This causes actuator 120 to drive lock pin 104 into proximalanchor 14. Lock pin 104 compresses a region of connector 16 between asurface of proximal anchor 14 and lock pin 104. This locks proximalanchor 14 to connector 16. Combined device 210 may further comprise amechanism to cut or trim the excess length of connector 16. In oneembodiment, the mechanism is similar to the cutting mechanism shown inFIGS. 5B-5D. In the step shown in FIG. 6W, combined device 210 iswithdrawn from the anatomy. This step leaves behind retractor 10comprising distal anchor 12 connected to proximal anchor 14 by connector16.

The various devices and methods disclosed herein or modificationsthereof may be used to retract, lift, support, reposition or compress aregion of a tubular anatomical organ such as the urethra. Such methodsmay also be used, for example, to reduce the cross sectional area of thelumen of a tubular anatomical organ. For example, the various devicesand methods disclosed herein or modifications thereof may be used toreduce the cross sectional area of the lumen of the urethra to treatincontinence, especially urinary stress incontinence. This may be doneby various devices that may be introduced in the urethra through avariety of approaches. Some examples of such approaches include, but arenot limited to transurethral approach, transvaginal approach,transperineal approach, etc.

FIGS. 7A through 7H show a longitudinal section of a tubular organshowing the steps of a method of reducing the cross sectional area ofthe lumen of the tubular organ. In the step shown in FIG. 7A, anelongate distal anchor delivery device 30 is introduced in the tubularorgan such as the urethra. In one particular embodiment, distal anchordelivery device 30 is introduced transurethrally into the urethra. Aneedle 32 is introduced through distal anchor delivery device 30. Thedistal region of needle 32 may comprise a curved region. Needle 32 mayexit distal anchor delivery device 30 at an exit angle ranging from 0degrees to 180 degrees to the axis of distal anchor delivery device 30.Needle 32 is advanced through the tubular organ such that needle 32penetrates through a wall of the tubular organ. In the step shown inFIG. 7B, distal anchor delivery device 30 is rotated. This causes needle32 to pull the tissue surrounding the wall of the tubular organ alongthe direction of rotation of distal anchor delivery device 30. In thestep shown in FIG. 7C, distal anchor delivery device 30 is rotatedfurther. This causes a region of the tissue surrounding the tubularorgan to fold around the tubular organ as shown in FIG. 7C. In the stepshown in FIG. 7D, a distal anchor 12 is delivered in the anatomy throughneedle 32. In the step shown in FIG. 7E, needle 32 is withdrawn from theanatomy through distal anchor delivery device 30. As shown in FIG. 7E,distal anchor 12 is attached to an elongate connector 16 that passesthrough distal anchor delivery device 30. In the step shown in FIG. 7F,distal anchor delivery device 30 is removed from the tubular organ overconnector 16. An elongate proximal anchor delivery device 34 isintroduced in the tubular organ over connector 16. This is done suchthat connector 16 passes through a proximal anchor 14 located onproximal anchor delivery device 34. Proximal anchor delivery device 34is advanced through the tubular organ such that the distal tip ofproximal anchor delivery device 34 is located near the site where needle32 punctured the wall of the tubular organ. In the step shown in FIG.7G, connector 16 is pulled by a user to introduce a desired tension inconnector 16. In the step shown in FIG. 7H, proximal anchor 14 isattached to connector 16. This may be done by a mechanism on proximalanchor delivery device 34 similar to the mechanism shown in FIGS. 5Bthrough 5D. Also, the excess length of connector 16 may be cut ortrimmed. This may be done by a mechanism on proximal anchor deliverydevice 34 similar to the mechanism shown in FIGS. 5B through 5D. Distalanchor delivery device 30 is removed from the anatomy. This step leavesbehind proximal anchor 14 connected to distal anchor 12 by connector 16.The tension in connector 16 causes the tissue between proximal anchor 14and distal anchor 12 to fold as shown in FIG. 7H. This in turn reducesthe cross sectional area of the lumen of the tubular organ.

FIG. 7I shows a schematic diagram of a tubular organ showing theconfiguration of the tubular organ before performing the method shown inFIGS. 7A through 7H. Examples of tubular organs that may be treated bythe method shown in FIGS. 7A through 7H include, but are not limited tourethra, bowel, stomach, esophagus, trachea, bronchii, bronchialpassageways, veins, arteries, lymphatic vessels, ureters, bladder,cardiac atria or ventricles, uterus, fallopian tubes, etc. FIG. 7J showsa schematic diagram of the tubular organ of FIG. 7I showing a possibleconfiguration obtained after performing the method shown in FIGS. 7Athrough 7H. In FIG. 7J, the tension in connector 16 causes the tissuebetween proximal anchor 14 and distal anchor 12 to twist. This in turnreduces the cross sectional area of the lumen of the tubular organ.

The method shown in FIGS. 7A through 7H may also be performed using adistal anchor delivery device comprising a helical needle. For example,FIG. 7K shows an embodiment of a distal anchor delivery device 30comprising a helical needle 32. In one method embodiment, distal anchordelivery device 30 is inserted into a tubular organ. Helical needle 32is advanced through distal anchor delivery device 30 such that thedistal region on needle 32 emerges out of distal anchor delivery device30. Needle 32 emerges out of distal anchor delivery device 30 andpenetrates the wall of the tubular organ. In one embodiment, the tubularorgan is the urethra UT comprising a urethral wall UW. The helical shapeof needle 32 causes at least a portion of helical needle 32 to curvearound the lumen of the tubular organ. Also, the helical shape of needle32 causes the distal tip of needle 32 to be axially spaced apart fromthe site where needle 32 penetrates into the wall of the tubular organ.A distal anchor 12 may be delivered into the anatomy from the distal tipof needle 32. Thus, distal anchor 12 may be delivered at a location thatis axially spaced apart from the penetration site of needle 32. Aproximal anchor 14 may be attached to connector 16 by a method similarto the method shown in FIGS. 7F-7H.

FIGS. 7L through 7N show a cross section of a tubular organ showing thesteps of a method of reducing the cross sectional area of the lumen ofthe tubular organ by creating one or more folds or pleats in the wallsof the tubular organ along the circumference of the lumen. FIG. 7L showsa cross section of a tubular organ. Examples of tubular organs that maybe treated by the method shown in FIGS. 7L through 7N include, but arenot limited to urethra UT, bowel, stomach, esophagus, trachea, bronchii,bronchial passageways, veins, arteries, lymphatic vessels, ureters,bladder, cardiac atria or ventricles, uterus, fallopian tubes, etc. Inthe step shown in FIG. 7M, an anchor delivery device comprising a curvedneedle 32 is introduced in the lumen of the tubular organ. Needle 32 isadvanced through the anchor delivery device such that the distal tip ofneedle 32 penetrates the wall of the tubular organ. Distal anchor 12 isadvanced through needle 32 and is delivered through the distal tip ofneedle 32 into the surrounding tissue. A desired tension is created inconnector 16 attached to distal anchor 12. A proximal anchor 14 isattached to a desired location on connector 16 to compress the tissuebetween proximal anchor 14 and distal anchor 12 as shown in FIG. 7N.This compression creates one or more folds or pleats in the walls of thetubular organ as shown in FIG. 7N. This in turn reduces the crosssectional area of the lumen of the tubular organ. In one embodiment,distal anchor delivery device 30 comprising a curved needle 32 isintroduced trans-urethrally in the urethra of a patient suffering fromurinary incontinence. Distal anchor 12 is deployed in the tissuesurrounding the urethra by distal anchor delivery device 30. Distalanchor delivery device 30 is removed from the urethra. Proximal anchordelivery device 34 is introduced trans-urethrally in the urethra overconnector 16. Proximal anchor 14 is attached to connector 16 by proximalanchor delivery device 34 such that proximal anchor 14 is located in thelumen of the urethra. Throughout this document wherever an anchor issaid to be placed within a body lumen, it is to be understood that suchanchor could be positioned within the lumen itself or at somesub-luminal or peri-luminal location, unless specified otherwise. Asuitable tension in connector 16 causes proximal anchor 14 and distalanchor 12 to compress the tissue between them. This compression createsone or more folds or pleats in the walls of the urethra as shown in FIG.7N. The one or more folds or pleats are preferably created in the regionof the urethra adjacent to a urinary sphincter. This enables the urinarysphincter to close more efficiently. This in turn reduces the undesiredleakage of urine through the urethra of the patient, thereby reducingthe severity of incontinence.

FIG. 7O shows a cross section of a tubular organ showing a firstembodiment of a method of compressing a tissue adjacent to a tubularorgan to cause one or more regions of the tissue to displace the wallsof the tubular organ thereby reducing the cross sectional area of thelumen of the tubular organ. In FIG. 7O, the urethra is used as anexample of a tubular organ that may be treated using the method. Otherexamples of tubular organs that may be treated by the method shown inFIG. 7O include, but are not limited to bowel, stomach, esophagus,trachea, bronchii, bronchial passageways, veins, arteries, lymphaticvessels, ureters, bladder, cardiac atria or ventricles, uterus,fallopian tubes, etc. In the method shown in FIG. 7O, proximal anchor 14is located in a lumen of the tubular organ. Proximal anchor 14 isconnected to one end of a connector 16 that is under a desired tension.The other end of connector 16 is connected to a distal anchor 12. Distalanchor 12 is implanted outside the lumen of the tubular organ. In oneembodiment, distal anchor 12 is implanted within a tissue locatedadjacent to the tubular organ. In another embodiment, distal anchor 12is implanted beyond a tissue located adjacent to the tubular organ. Thetension in connector 16 causes proximal anchor 14 and distal anchor 12to compress a region of the tissue located adjacent to the tubularorgan. This causes one or more regions of the tissue located adjacent tothe tubular organ to bulge and displace one or more regions of the wallof the tubular organ. This in turn reduces the cross sectional area ofthe lumen of the tubular organ.

FIG. 7P shows a cross section of a tubular organ showing a secondembodiment of a method of compressing a tissue adjacent to a tubularorgan to cause one or more regions of the tissue to displace the wallsof the tubular organ thereby reducing the cross sectional area of thelumen of the tubular organ. In FIG. 7P, the urethra is used as anexample of a tubular organ that may be treated using the method. Otherexamples of tubular organs that may be treated by the method shown inFIG. 7P include, but are not limited to bowel, stomach, esophagus,trachea, bronchii, bronchial passageways, veins, arteries, lymphaticvessels, ureters, bladder, cardiac atria or ventricles, uterus,fallopian tubes, etc. In the method shown in FIG. 7P, proximal anchor 14is located on one side of a tissue located adjacent to the tubularorgan. Proximal anchor 14 is connected to one end of a connector 16 thatis under a desired tension. The other end of connector 16 is connectedto a distal anchor 12. Distal anchor 12 is implanted on the oppositeside of the tissue located adjacent to the tubular organ. The tension inconnector 16 causes proximal anchor 14 and distal anchor 12 to compressa region of the tissue. This in turn causes one or more regions of thetissue located adjacent to the tubular organ to bulge and displace oneor more regions of the wall of the tubular organ as shown in FIG. 7P.This in turn reduces the cross sectional area of the lumen of thetubular organ.

FIGS. 7Q through 7V show longitudinal sections of a tubular organshowing the steps of a method of reducing the cross sectional area ofthe lumen of the tubular organ by creating one or more folds or bulgesin the walls of the tubular organ along the axis of the tubular organ.In the step shown in FIG. 7Q, a distal anchor delivery device 30 isintroduced in a tubular organ. In FIGS. 7Q-7V, the urethra is used as anexample of a tubular organ that may be treated using the method. Otherexamples of tubular organs that may be treated by the method shown inFIGS. 7Q to 7V include, but are not limited to bowel, stomach,esophagus, trachea, bronchii, bronchial passageways, veins, arteries,lymphatic vessels, ureters, bladder, cardiac atria or ventricles,uterus, fallopian tubes, etc. Distal anchor delivery device 30 comprisesa bendable distal tip. The bendable distal tip can be controllably bentby a user. Distal anchor delivery device 30 is advanced through thetubular organ and positioned in a desired location. In the step shown inFIG. 7R, the distal tip of distal anchor delivery device 30 iscontrollably bent by the user. In the step shown in FIG. 7S, a needle 32is advanced through distal anchor delivery device 30. Needle 32 emergesout of distal anchor delivery device 30 at an angle to the axis ofdistal anchor delivery device 30 as shown in FIG. 7S. Needle 32 isadvanced such that it penetrates through a region of the wall of thetubular organ at a penetration site. Needle 32 is further advanced suchthat it reenters the lumen of the tubular organ. This step may bevisualized by an endoscope located in the lumen of the tubular organ. Inthe step shown in FIG. 7T, a distal anchor 12 is deployed through thedistal tip of needle 32. Distal anchor delivery device 30 is withdrawnfrom the tubular organ leaving distal anchor 12 connected to a connector16. In the step shown in FIG. 7U, a proximal anchor delivery device 34is advanced over connector 16. Proximal anchor delivery device 34 isadvanced until the distal region of proximal anchor delivery device 34is adjacent to the penetration site of needle 32. Connector 16 is pulledto create a desired tension in connector 16. Proximal anchor 14 isattached to connector 16 in the lumen of the tubular organ. The tensionin connector 16 causes proximal anchor 14 and distal anchor 12 tocompress the region of the wall of the tubular organ located betweenproximal anchor 14 and distal anchor 12. This in turn causes one or moreregions of the wall of the tubular organ to fold or bulge into the lumenof the tubular organ as shown in FIG. 7V. This in turn creates one ormore folds or bulges in the walls of the tubular organ along the axis ofthe tubular organ. The one or more folds or bulges reduce the crosssectional area of the lumen of the tubular organ. This method can berepeated to compress multiple regions of the wall of the tubular organto create multiple bulges in the wall of the tubular organ. In onemethod embodiment, the one or more folds or bulges are preferablycreated in the region of the urethra adjacent to a urinary sphincter ofa patient suffering from incontinence. This enables the urinarysphincter to close more efficiently. This in turn reduces the undesiredleakage of urine through the urethra of the patient, thereby reducingthe severity of incontinence.

FIGS. 7W through 7Y shows cross sections of a tubular organ showing thesteps of a first embodiment of a method of reducing the cross sectionalarea of the lumen of the tubular organ by implanting a device thatpinches the walls of the tubular organ to create a recess. In FIGS.7W-7Y, the urethra is used as an example of a tubular organ that may betreated using this method. Other examples of tubular organs that may betreated by the method shown in FIGS. 7W-7Y include, but are not limitedto urethra, blood vessels, bowel, stomach, esophagus, trachea, bronchii,bronchial passageways, veins, arteries, lymphatic vessels, ureters,bladder, cardiac atria or ventricles, uterus, fallopian tubes, etc. Adistal anchor delivery device is introduced in the anatomy. The distalanchor delivery device is used to penetrate through the lumen of atubular organ and deploy a distal anchor 12 in the walls of the tubularorgan or in the surrounding anatomy as shown in FIG. 7W. Distal anchor12 is connected to a connector 16 that passes through the lumen of thetubular organ. In the step shown in FIG. 7X, a proximal anchor 14 isadvanced over connector 16. Proximal anchor 14 is advanced overconnector 16 such that proximal anchor 14 is proximal to the lumen ofthe tubular organ. Proximal anchor 14 may be located in the walls of thetubular organ or in the surrounding anatomy. Connector 16 is pulled tocreate a desired tension in connector 16. The tension in connector 16causes proximal anchor 14 and distal anchor 12 to pinch a region of thetubular organ located between them. This in turn creates a recess orfold in the wall of the tubular organ as shown in FIG. 7Y. Proximalanchor 14 is attached to connector 16 in the lumen of the tubular organ.The excess length of connector 16 may be cut or trimmed. The recess orfold in the wall of the tubular organ reduces the cross sectional areaof the lumen of the tubular organ. The steps shown in FIGS. 7W-7Y may berepeated to create multiple recesses or folds in the walls of thetubular organ. Such a method may be used to treat a variety of diseasesincluding, but not limited to incontinence, emphysema, obesity, vaginalprolapse, aneurysms, diverticuli, etc.

FIGS. 7Z through 7AD show cross sections of a tubular organ showing thesteps of a second embodiment of a method of reducing the cross sectionalarea of the lumen of the tubular organ by implanting a device thatpinches the walls of the tubular organ to create a recess. In FIGS.7Z-7AD, the urethra is used as an example of a tubular organ that may betreated using this method. Other examples of organs that may be treatedby the method shown in FIGS. 7Z-7AD include, but are not limited tobowel, stomach, esophagus, trachea, bronchii, bronchial passageways,veins, arteries, lymphatic vessels, ureters, bladder, cardiac atria orventricles, uterus, fallopian tubes, etc. A distal anchor deliverydevice is introduced in the anatomy. The distal anchor delivery devicemay be introduced, for example, transluminally through the lumen of thetubular organ. The distal anchor delivery device is used to penetratethrough a wall of the tubular organ. The distal anchor delivery deviceis used to deploy a distal anchor 12 in the wall of the tubular organ orin the surrounding anatomy as shown in FIG. 7Z. Distal anchor 12 isconnected to a connector 16 that passes through the lumen of the tubularorgan. Similarly, in the step shown in FIG. 7AA, a second distal anchor12 is deployed in the wall of the tubular organ or in the surroundinganatomy. The second distal anchor 12 is also connected to a secondconnector 16 that passes through the lumen of the tubular organ. In thestep shown in FIG. 7AB, a connecting device 214 is introduced in thelumen of the tubular organ over the two connectors 106. Connectingdevice 214 may be introduced, for example, transluminally through thelumen of the tubular organ. The two connectors 106 are pulled to createa desired tension in the two connectors 106. The tensions in the twoconnectors 106 cause the two distal anchors 102 to pinch a region of thetubular organ located between them. This in turn creates a recess orfold in the wall of the tubular organ as shown in FIG. 7AC. A desiredregion of the first connector is connected to a desired region of thesecond connector 16 by connecting device 214. This connection is createdin the lumen of the tubular organ as shown in FIG. 7AD. The excesslength of connectors 106 may be cut or trimmed. The recess or fold inthe wall of the tubular organ reduces the cross sectional area of thelumen of the tubular organ. The steps shown in FIGS. 7Z-7AD may berepeated to create multiple recesses or folds in the walls of thetubular organ. Such a method may be used to treat a variety of diseasesincluding, but not limited to incontinence, emphysema, obesity, vaginalprolapse, aneurysms, diverticuli, etc.

The methods and devices disclosed herein may be used to create multiplefolds, bulges or recesses in the walls of a tubular organ to reduce thecross sectional area of the lumen of the tubular organ. For example,FIG. 7AE shows a cross section of a tubular organ showing a firstembodiment of a method of reducing the cross sectional area of the lumenof the tubular organ by implanting devices that pinch the walls of thetubular organ to create two recesses. In FIG. 7AE, a first anchoringsystem comprising a proximal anchor 14 and a distal anchor 12 connectedby a connector 16 is deployed as shown. The tension in connector 16causes distal anchor 12 and proximal anchor 14 to pinch a region of thetubular organ located between them. This in turn creates a first recessor fold in the wall of the tubular organ as shown. Proximal anchor 14,distal anchor 12 and connector 16 may be deployed in the anatomy, forexample, by the method shown in FIGS. 7W-7Y. Alternatively, proximalanchor 14, distal anchor 12 and connector 16 may be deployed in theanatomy by the method shown in FIGS. 7Z-7AD. A second anchoring systemcomprising a proximal anchor 14 and a distal anchor 12 connected by aconnector 16 is also deployed as shown. The second anchoring systemcreates a second recess or fold in the wall of the tubular organ asshown. In the embodiment shown in FIG. 7AE, the second recess or fold iscreated at a location that is roughly diametrically opposite to thefirst recess or fold.

FIG. 7AF shows a cross section of a tubular organ showing a secondembodiment of a method of reducing the cross sectional area of the lumenof the tubular organ by implanting devices that pinch the walls of thetubular organ to create two recesses. In FIG. 7AF, a first anchoringsystem comprising a proximal anchor 14 and a distal anchor 12 connectedby a connector 16 is deployed as shown. The tension in connector 16causes distal anchor 12 and proximal anchor 14 to pinch a region of thetubular organ located between them. This in turn creates a first recessor fold in the wall of the tubular organ as shown. Proximal anchor 14,distal anchor 12 and connector 16 may be deployed in the anatomy, forexample, by the method shown in FIGS. 7W-7Y. Alternatively, proximalanchor 14, distal anchor 12 and connector 16 may be deployed in theanatomy by the method shown in FIGS. 7Z-7AD. A second anchoring systemcomprising a proximal anchor 14 and a distal anchor 12 connected by aconnector 16 is also deployed as shown. The second anchoring systemcreates a second recess or fold in the wall of the tubular organ asshown. In the embodiment shown in FIG. 7AF, the second recess or fold iscreated at a location that is not diametrically opposite to the firstrecess or fold.

The methods and devices disclosed herein may be used to reinforce afold, bulge or recess in the walls of a tubular organ to further reducethe cross sectional area of the lumen of the tubular organ. For example,FIG. 7AG shows a cross section of a tubular organ showing a method ofreducing the cross sectional area of the lumen of the tubular organ bycreating a recess in the walls of the tubular organ and reinforcing therecessed region. In FIG. 7AG, a first anchoring system comprising aproximal anchor 14 and a distal anchor 12 connected by a connector 16 isdeployed in a tubular organ. The tension in connector 16 causes distalanchor 12 and proximal anchor 14 to pinch a region of the tubular organlocated between them. This in turn creates a recess or fold in the wallof the tubular organ as shown. Proximal anchor 14, distal anchor 12 andconnector 16 may be deployed in the anatomy, for example, by the methodshown in FIGS. 7W-7Y. Alternatively, proximal anchor 14, distal anchor12 and connector 16 may be deployed in the anatomy by the method shownin FIGS. 7Z-7AD. A second anchoring system comprising a proximal anchor14 and a distal anchor 12 connected by a connector 16 is also deployedas shown. The second anchoring system is deployed in the recess or foldcreated by the first anchoring system in the wall of the tubular organ.The second anchoring system reinforces the recess or fold created by thefirst anchoring system. The second anchoring system may also increasethe size of the recess or fold created by the first anchoring system.This in turn may further reduce the cross sectional area of the lumen ofthe tubular organ. It should also be understood that variations in theprocedure may be usable to subtly alter the shape of the lumen of thetubular organ or may be usable to remove deformities or pockets in thelumen, for example, closing or compressing diverticuli or aneurysmicmorphologies.

The various devices and methods disclosed herein may be used to preventor treat a variety of diseases or disorders of a variety of anatomicalsystems. Examples of such anatomical systems include, but are notlimited to the musculoskeletal system, the gastrointestinal system, theurinary system, etc. For example, FIG. 8A shows an anchoring systemimplanted in a stomach to reduce the volume of the stomach to treatobesity. The anchoring system comprises a proximal anchor 14 connectedto a distal anchor 12 by a connector 16. Proximal anchor 14 is locatedon the outer surface or within the wall of the stomach of an obesepatient. Similarly, distal anchor 12 is located on the outer surface orwithin the wall of the stomach of the obese patient. Connector 16 passesthrough the lumen of the stomach. The tension in connector 16 causesproximal anchor 14 and distal anchor 12 to compress a region of stomachlocated between them. This in turn reduces the volume of the stomach.This in turn restricts the volume of intake of food by the patient,thereby causing weight loss.

FIG. 8B shows a cross sectional view of a stomach before implanting ananchoring system to reduce the volume of the stomach. FIG. 8C shows across sectional view of the stomach of FIG. 8B after implanting ananchoring system to reduce the volume of the stomach. In FIG. 8C, thevolume of the stomach is reduced by implanting an anchoring system. Theanchoring system comprises a proximal anchor 14 connected to a distalanchor 12 by a connector 16.

The various devices and methods disclosed herein may be used to close orrepair wounds. For example, FIG. 8D shows a section through wound edgesclosed by an anchoring system in a first configuration. In FIG. 8D, awound comprising two wound edges is closed by an anchoring systemcomprising a proximal anchor 14 connected to a distal anchor 12 by aconnector 16. The tension in connector 16 causes proximal anchor 14 anddistal anchor 12 to compress the wound edges. This in turn brings thewound edges close to each other, thereby closing the wound. In theembodiment shown in FIG. 8D, the wound edges are closed in aside-to-side configuration. The anchoring system shown in FIG. 8D may bedeployed, for example, by distal anchor delivery device 30 and proximalanchor delivery device 34 of FIGS. 6A and 6C respectively. Connector 16may be fully or partially biodegradable or bioabsorbable.

FIG. 8E shows a section through wound edges closed by an anchoringsystem in a second configuration. In FIG. 8E, a wound comprising twowound edges is closed by an anchoring system comprising a proximalanchor 14 connected to a distal anchor 12 by a connector 16. The tensionin connector 16 causes proximal anchor 14 and distal anchor 12 tocompress the wound edges. This in turn brings the wound edges close toeach other, thereby closing the wound. In the embodiment shown in FIG.8D, the wound edges are closed in an end-to-end configuration. Theanchoring system shown in FIG. 8D may be deployed, for example, bydistal anchor delivery device 30 and proximal anchor delivery device 34of FIGS. 6A and 6C respectively. Distal anchor delivery device 30 maycomprise a curved distal tip. Connector 16 may be fully or partiallybiodegradable or bioabsorbable.

FIG. 8F shows an anchoring device used to reconnect torn tissues of themusculoskeletal system. In FIG. 8F, an anchoring system is used toreconnect a torn ligament Li. In the normal anatomy, one piece of theligament Li is connected to bone Bo, and the other piece of ligament Liis connected to a muscle. The anchoring system comprises a proximalanchor 14 connected to a distal anchor 12 by a connector 16. The tensionin connector 16 causes proximal anchor 14 and distal anchor 12 tocompress the ends of the two pieces of ligament Li. This in turn bringsthe two pieces of ligament Li close to each other, thereby joining thetorn ligament Li as shown in FIG. 8F. Similarly, other torn tissues ofthe musculoskeletal system such as torn muscles may be reconnected by ananchoring system.

FIG. 8G shows a sagittal section through the head of a patient sufferingfrom sleep apnea. In FIG. 8G, the soft palate SP of the patient isblocking the flow of air from the nostrils to the lungs. Also, in FIG.8G, the tongue TO of the patient is obstructing the fluid path from themouth to the pharynx. Thus, the patient is unable to breathe normally.

FIG. 8H shows a sagittal section through the head of a patient sufferingfrom sleep apnea who has been treated with two anchoring devices thatdisplace the obstructing portions of the soft palate SP and the tongueTo. In FIG. 8H, an anchoring system comprising a proximal anchor 14connected to a distal anchor 12 by a connector 16 is implanted in theposterior region of the soft palate SP. The tension in connector 16causes proximal anchor 14 and distal anchor 12 to compress a region ofthe soft palate SP. This in turn displaces the obstructing region of thesoft palate SP as shown. Thus, the flow of air from the nostrils to thelungs is not blocked by the soft palate SP. In addition, oralternatively, a region of the tongue TO may also be displaced by ananchoring system. In FIG. 8F, the anchoring system comprises a proximalanchor 14 connected to a distal anchor 12 by a connector 16. The tensionin connector 16 causes proximal anchor 14 and distal anchor 12 tocompress a posterior region of the tongue TO. This in turn displaces theobstructing region of the tongue TO as shown. Thus, the fluid path fromthe mouth to the lungs is not blocked by the tongue TO. Multipleanchoring systems may be used to displace obstructing regions of thesoft palate SP and/or obstructing regions of the tongue TO.

The devices and systems disclosed herein may be used for a variety ofcosmetic procedures. For example, FIG. 8I shows an anchoring system thatis implanted to lift loose skin in the face of a human. Such ananchoring system may be used, for example, to lift wrinkled skin tosmoothen wrinkles. In FIG. 8I, an anchoring system comprising a proximalanchor 14 connected to a distal anchor 12 by a connector 16 is implantedin the tissues of the face as shown. In the embodiment shown in FIG. 8I,distal anchor is implanted behind an ear of the patient. Proximal anchor14 is implanted in a region of the cheek of the patient having wrinkledfacial skin. The tension in connector 16 causes proximal anchor 14 anddistal anchor 12 to displace the region of the cheek having wrinkledfacial skin. This in turn stretches the wrinkled facial skin to improvethe cosmetic appearance of the human. Similar methods may be used tolift sagging facial skin to improve the cosmetic appearance of a human.

Various regions of the face may be treated by methods similar to themethod shown in FIG. 8J. For example, FIG. 8J shows a view of a humanface showing facial regions that may be treated by a method similar tothe method shown in FIG. 8I to improve the cosmetic appearance of thehuman. One example of a facial region that can be treated by a methodsimilar to the method shown in FIG. 8I is the eyebrow zone. A proximalanchor 14 may be implanted in the region EB and a distal anchor 12 maybe implanted in a region EB′. Proximal anchor 14 is connected to distalanchor 12 by a connector 16 that passes through the line joining regionEB to region EB′. In an alternate embodiment, proximal anchor 14 may beimplanted in the region EB′ and a distal anchor 12 may be implanted in aregion EB. Another example of a facial region that can be treated by amethod similar to the method shown in FIG. 8I is the temporal zone. Aproximal anchor 14 may be implanted in the region TE and a distal anchor12 may be implanted in a region TE′. Proximal anchor 14 is connected todistal anchor 12 by a connector 16 that passes through the line joiningregion TE to region TE′. In an alternate embodiment, proximal anchor 14may be implanted in the region TE′ and a distal anchor 12 may beimplanted in a region TE. Another example of a facial region that can betreated by a method similar to the method shown in FIG. 8I is the malarzone. A proximal anchor 14 may be implanted in the region MA and adistal anchor 12 may be implanted in a region MA′. Proximal anchor 14 isconnected to distal anchor 12 by a connector 16 that passes through theline joining region MA to region MA′. In an alternate embodiment,proximal anchor 14 may be implanted in the region MA′ and a distalanchor 12 may be implanted in a region MA. Another example of a facialregion that can be treated by a method similar to the method shown inFIG. 8I is the mandibular zone. A proximal anchor 14 may be implanted inthe region MD and a distal anchor 12 may be implanted in a region MD′.Proximal anchor 14 is connected to distal anchor 12 by a connector 16that passes through the line joining region MD to region MD′. In analternate embodiment, proximal anchor 14 may be implanted in the regionMD′ and a distal anchor 12 may be implanted in a region MD. Anotherexample of a facial region that can be treated by a method similar tothe method shown in FIG. 8I is the neckerchief zone. A proximal anchor14 may be implanted in the region NK and a distal anchor 12 may beimplanted in a region NK′. Proximal anchor 14 is connected to distalanchor 12 by a connector 16 that passes through the line joining regionNK to region NK′. In an alternate embodiment, proximal anchor 14 may beimplanted in the region NK′ and a distal anchor 12 may be implanted in aregion NK. The facial regions shown in FIG. 8J may be treated, forexample, to improve the cosmetic appearance of a human with wrinkled orsagging facial skin.

FIG. 8K shows a sagittal section through the lower abdomen of a humanfemale showing an embodiment of a method of treating female urinaryincontinence by a sling attached to the anatomy by anchoring devices.FIG. 8K shows the lower abdomen of a human female showing the urinarybladder UB, uterus U and rectum R. The method shown in FIG. 8K isespecially suited to treat stress incontinence caused due to physicalchanges because of pregnancy, childbirth, menopause, etc. The physicalchanges prevent the urethral sphincter from closing tightly. This inturn causes urine to leak during moments of physical stress. The methodshown in FIG. 8K is similar to the Tension-Free Vaginal Tape (TVT)Procedure. In the method shown in FIG. 8K, a sling 220 is insertedaround the urethra UT. Sling 220 may be inserted around the urethra UTby a retropubic or transvaginal approach. Sling 220 is made of suitablebiocompatible materials. Examples of such materials include, autologousgraft tissue such as muscles, ligaments, tendons, etc.; animal grafttissue from animals such as pigs, etc.; synthetic biodegradable ornon-biodegradable polymers, etc. The two ends of sling 220 are anchoredto surrounding anatomical regions such as the pubic bone, periostialmembrane of the pubic bone, Cooper's ligament, abdominal wall, lateralpelvic wall, outer bladder wall, pelvic fascia by anchoring devices. Inthe embodiment shown in FIG. 8K, the two ends of sling 220 are attachedto the surrounding anatomical structures by two anchoring devices. Eachanchoring device comprises a proximal anchor 14 and a distal anchor 12connected to proximal anchor 14 by a connector. Connector 16 passesthrough an end of sling 220 such that proximal anchor 14 is anchored inthe material of sling 220. Distal anchor 12 anchors into the surroundinganatomical structures, thereby attaching the end of sling 220 to thesurrounding anatomical structures. Sling 220 supports the urethra UT andpartially compresses the urethra UT. Sling 220 cause a sufficientcompression of the urethra UT to enable urethral sphincter to closetightly. It should be noted that the intent of these procedures is notin all cases to create compression on the urethra but in othersituations is used to support surrounding structures or prevent themovement of certain structures under certain conditions, such as in thecase of hypermobility. In this circumstance, the devices would normallybe “tension-free” and would only be brought into tension when there ismovement of the tissue with respect to the anchor/tensioning-memberassembly.

FIG. 8L shows a cross section of a normal urethra UT. FIG. 8M shows across section of the urethra UT in a human female suffering from stressurinary incontinence. In FIG. 8M, the urethra UT has reduced supportfrom surrounding anatomical structures. This prevents the urethralsphincter from closing tightly causing incontinence. FIG. 8N shows across section of the urethra UT in a human female suffering from stressurinary incontinence where the urethra UT has been supported with asling. In FIG. 8N, sling 220 supports the urethra UT and partiallycompresses the urethra UT. Sling 220 causes a sufficient compression ofthe urethra UT to enable urethral sphincter to close tightly. This inturn reduces the severity of the incontinence.

FIG. 8O shows a coronal section through the lower abdomen of a humanfemale suffering from stress urinary incontinence. Two anchoring deviceshave been implanted in order to tether together separate tissue planes.The tethering of these planes reduces their relative movement; thusreducing hypermobility. Each anchoring device comprises a proximalanchor 14 and a distal anchor 12 connected to proximal anchor 14 by aconnector that passes through separate tissue planes. Tissue planessupports the urethra UT and may partially compresses the urethra UT.With this supportive tissue plane now fixed in place, forces which wouldotherwise have caused the involuntary descent of the bladder resultingin incontinence are now apposed.

One or more anchoring or tensioning devices disclosed herein may be usedto anchor a first anatomical region to a second anatomical region. Forexample, one or more anchoring or tensioning devices disclosed hereinmay be used to perform various embodiments or modifications ofcolposuspension procedures. In the standard colposuspension procedure(Burch colposuspension) a surgeon sutures a region of the vaginal wallto the Cooper's ligament. This is performed by placing twonon-absorbable sutures on each side of the urethra, partially throughthe segment of the vaginal wall located under the junction where thebladder joins the urethra. The two sutures on each side (four total) arethen attached to the Cooper's ligament. A key difficulty in performingthis procedure is the step of tying a knot, especially when theprocedure is performed laparoscopically. The need to synch and tiesutures sequentially through a laparoscope is very time consuming usingstandard techniques and it is often difficult to achieve the desiredsuture tension. For example, FIG. 8P shows a section through the lowerabdomen showing an embodiment of a colposuspension procedure wherein oneor more regions of the vaginal wall of a patient suffering fromincontinence are suspended to the Cooper's ligament by one or moreanchoring devices. In the embodiment shown in FIG. 8P, one or moredistal anchors 102 are deployed in a desired region of the Cooper'sligament by a device introduced through the vagina V. The one or moredistal anchors 102 may be deployed through a needle that emerges throughthe device introduced through the vagina and penetrate through thevaginal wall to reach the desired location. The one or more distalanchors 102 are deployed on each side of the urethra as shown in FIG.8P. Each distal anchor 12 is connected to a connector 16. A proximalanchor 106 is attached to a desired region of each connector 16 locatedin the vagina. Each proximal anchor 14 anchors one end of each connector16 to the vaginal wall. The tension in connector 16 causes the vaginalwall to be suspended by Cooper's ligament. The suspension of the vaginalwall to the Cooper's ligament reduces the severity of the incontinence.The abovementioned method may be visualized by a laparoscope inserted inthe pelvic area.

In an alternate embodiment, the devices for deploying proximal anchor 14and/or distal anchor 12 are inserted laparoscopically into the pelvicarea. A laparoscope may be used to visualize the instruments. In oneembodiment, the laparoscope is introduced through the navel. The devicesfor deploying proximal anchor 14 and/or distal anchor 12 are introducedthrough two other incisions in the lower abdomen.

One or more devices or methods disclosed herein may be used to attach aplugging element to a tubular organ to seal an opening or a puncturesite of the tubular organ. For example, FIG. 8Q shows an anchoringdevice used to attach a seal to a puncture site on a blood vessel BV toseal the puncture site. In FIG. 8Q, the puncture site on the bloodvessel is plugged by a seal 222. Seal 222 is made of suitablebiocompatible materials. Examples of such materials include, but are notlimited to collagen, gelfoam, other bioabsorbable polymer matrices, etc.Seal 222 is attached to the puncture site by an anchoring device thatpasses through seal 222. The anchoring device comprises a distal anchor12, a proximal anchor 14 and a connector 16 that connects distal anchor12 to proximal anchor 14. Distal anchor 12 is located in the lumen ofthe blood vessel. Proximal anchor 14 is located outside the bloodvessel, such that connector 16 passes through the puncture site. Asufficient tension is created in connector 16 such that distal anchor 12and proximal anchor 14 compress the edges of the puncture site to seal222. This in turn securely attaches seal 222 to the edges of thepuncture site, thereby sealing the puncture site.

One or more anchoring or tensioning devices disclosed herein may be usedto suspend a first anatomical region to a second anatomical region. Forexample, one or more anchoring or tensioning devices disclosed hereinmay be used to suspend a breast region to an anatomical region superioranatomical region such as a muscle, subcutaneous fatty tissue, aligament, etc. This may be used to achieve cosmetic modification of thebreasts. In a particular embodiment, a subcutaneous fatty tissue of abreast is suspended to an anatomical region superior to the fatty tissuesuch as a muscle, a subcutaneous fatty tissue, a ligament, etc. Inanother particular embodiment, a breast tissue is suspended to ananatomical region superior to the breast tissue such as a muscle, asubcutaneous fatty tissue, a ligament, etc. The anchor delivery devicesmay be introduced in the anatomy through a cannula. Alternatively theanchor delivery device may comprise a sharp distal tip to penetratethrough tissue. For example, FIG. 8R shows a view of the pectoral regionof a human female. A region of a breast may be suspended to ananatomical region superior to the region of the breast using theanchoring devices disclosed herein. This may be used, for example, forcosmetic mastopexy. The anchoring devices may be deployed such that theconnectors of the anchoring devices pass through the dashed lines shownin FIG. 8R. FIG. 8S shows the pectoral region of a human female whereinmastopexy has been performed on one or more regions of the breasts usingthe anchoring devices disclosed herein.

Any of the anchors disclosed herein may be made of suitable elastic ornon-elastic biocompatible materials. Examples of such materials include,but are not limited to metals such as stainless steel 304, stainlesssteel 316, nickel-Titanium alloys, titanium, etc. and polymers such asPebax, Polyimide, braided Polyimide, Polyurethane, Nylon, PVC, Hytrel,HDPE, PEEK, PTFE, PFA, FEP, EPTFE, shape memory polymers, etc.

Connector 16 described herein may be made from several biocompatiblematerials. For example, connector 16 may be made from synthetic fiberse.g. various grades of Nylon, polyethylene, polypropylene, polyester,Aramid, shape memory polymers, etc.; metals e.g. various grades ofstainless steel, titanium, nickel-titanium alloys, cobalt-chromiumalloys, tantalum etc.; natural fibers e.g. cotton, silk etc.; rubbermaterials e.g. various grades of silicone rubber, etc. In a particularembodiment, connector is made of elastic suture materials. Connector 16may comprise one or more serrations or notches. The serrations ornotches may be aligned in a particular direction to allow relativelyeasy movement of an outer body along connector 16 in one direction andoffer significant resistance to movement of the outer body along theconnector 16 in the opposite direction. Connector 16 may comprise asingle filament or multiple filaments of one or more materials. Forexample, connector 16 may comprise a composite braided structure in aplastic/metal or plastic/plastic configuration to reduce profile andincrease strength. Such composite materials could have preset levels ofelasticity. Connector 16 may be coated with a coating. Examples of suchcoatings include, but are not limited to lubricious coatings, antibioticcoatings, etc.

One or more of the devices disclosed herein may comprise a variety ofmarkers. In one embodiment, the markers are visual markers located onthe surface of the one or more devices. Such markers may enable a userto determine the absolute of relative location of the one or moredevices visually or by an instrument such as a cystoscope. In anotherembodiment the markers may be radiographic markers. Similarly, one ormore of the devices disclosed herein may comprise a variety ofelectromagnetic or ultrasonic or MRI or multimodality markers.

A suitable urinary catheter may be inserted into the urethra for adesired period of time after completion of one or more of the proceduresdescribed herein. The urinary catheter may be used, for example, if thepatient is at risk of bleeding or acute urethral obstruction.

The one or more anchoring devices disclosed herein may be designed toallow a user to reverse the anatomical changes caused by the anchoringdevices if needed. In one method embodiment the anatomical changes maybe reversed by cutting connector 16 near proximal anchor 14. In anothermethod embodiment the anatomical changes may be reversed by cuttingconnector 16 near distal anchor 12.

One or more components such as distal anchor 12, proximal anchor 14,connector 16, etc. of the one or more anchoring devices disclosed hereinmay be designed to be completely or partially biodegradable orbiofragmentable.

The devices and methods disclosed herein may be used to treat a varietyof pathologies in a variety of tubular organs or organs comprising acavity or a wall. Examples of such organs include, but are not limitedto urethra, bowel, stomach, esophagus, trachea, bronchii, bronchialpassageways, veins (e.g. for treating varicose veins or valvularinsufficiency), arteries, lymphatic vessels, ureters, bladder, cardiacatria or ventricles, uterus, fallopian tubes, etc.

It is to be appreciated that the invention has been described hereabovewith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to those examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unpatentable or unsuitable for its intended use.Also, for example, where the steps of a method are described or listedin a particular order, the order of such steps may be changed unless todo so would render the method unpatentable or unsuitable for itsintended use. All reasonable additions, deletions, modifications andalterations are to be considered equivalents of the described examplesand embodiments and are to be included within the scope of the followingclaims.

1. A system for manipulation of anatomic structure found at aninterventional site, comprising: an elongate sheath; a rigid endoscopereceived in the elongate sheath; at least one anchor assembly, theanchor assembly including a first anchor member, a second anchor member,and a connector joining the first and second anchor members; an anchordelivery device inserted in the elongate sheath, the anchor deliverydevice including a needle, a delivery tube housing the first and secondanchor members, a handle at a right angle to the delivery tube, a firstactuator and a second actuator each configured next to the handle andbeing configured to receive and deploy the anchor assembly; whereinmanipulation of the first actuator accomplishes advancing the needlealong a curved path in the delivery tube housing, gaining access to afirst site and deployment of the first anchor member independently ofthe second anchor member.
 2. A system including an anchor assembly forassembly within a patient's body, comprising: an elongate sheath; arigid endoscope received in the elongate sheath; an anchor deliverydevice inserted in the elongate sheath, the anchor delivery deviceincluding a needle, a delivery tube, a handle at a right angle to thedelivery tube, a first actuator adjacent the handle that advances theneedle, and a second actuator adjacent the handle; a first anchormember; a second anchor member including a first part and a second part;a connector joining the first and second anchor members; wherein thefirst and second anchor members and the connector are housed in thedelivery tube and the needle is advanced along a curved path in thedelivery tube; wherein the first and second parts are configured to bejoined with the connector and each other within a patient's body uponactivation of the second actuator.
 3. The system of claim 2, wherein theanchor delivery device is configured to accomplish the assembly of theanchor assembly within a patient's body and the implantation of anassembled anchor assembly at an intervention site.
 4. The system ofclaim 3, wherein the first part is embodied in a generally tubularmember.
 5. The system of claim 4, wherein the second part is embodied ina pin sized to both receive the connector and to form a lockingengagement with the first part.
 6. A system for implanting an anchorassembly, comprising: an elongate sheath; a rigid endoscope received inthe elongate sheath; at least one anchor assembly, the anchor assemblyincluding a first anchor member, a second anchor member, and a connectorjoining the first and second anchor members; and an anchor deliverydevice inserted in the elongate sheath, the anchor delivery deviceincluding a needle, a delivery tube housing the anchor assembly, ahandle at a right angle to the delivery tube, a first trigger and asecond trigger each adjacent the handle; wherein actuation of the firsttrigger accomplishes advancing the needle along a curved path in thedelivery tube housing, gaining access to a first site, deployment of thefirst anchor member independently of the second anchor member, andassembly of the second anchor member. sheath, the anchor delivery deviceincluding a needle, a delivery tube housing the anchor assembly, ahandle at a right angle to the delivery tube, a first trigger and asecond trigger, wherein actuation of the first trigger advances theneedle along a curved path in the delivery tube housing and actuation ofthe second trigger accomplishes complete delivery of one anchorassembly.
 7. A system including an anchor assembly for assembly within apatient's body, comprising: an elongate sheath; a rigid endoscopereceived in the elongate sheath; a delivery device inserted in theelongate sheath including a delivery tube, a needle, a handle at a rightangle to the delivery tube and first and second triggers adjacent thehandle; a first anchor member housed within the delivery tube; a secondanchor member including a first part and a second part housed in thedelivery tube; a connector joining the first and second anchor members;wherein one or both of the first and second parts are configured to bejoined with the connector and each other within a patient's body;wherein the first actuator of the trigger advances the needle along acurved path in the delivery tube and actuation of the second triggeraccomplishes the assembly of the anchor assembly within a patient's bodyand accomplishes the implantation of an assembled anchor assembly.